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  1. 1 INDICATIONS AND USAGE
  2. 2 DOSAGE AND ADMINISTRATION
  3. 3 DOSAGE FORMS AND STRENGTHS
  4. 4 CONTRAINDICATIONS
  5. 5 WARNINGS AND PRECAUTIONS
  6. 6 ADVERSE REACTIONS
  7. 8 USE IN SPECIFIC POPULATIONS
  8. 11 DESCRIPTION
  9. 12 CLINICAL PHARMACOLOGY
  10. 13 NONCLINICAL TOXICOLOGY
  11. 14 CLINICAL STUDIES
  12. 16 HOW SUPPLIED/STORAGE AND HANDLING


It is very important to know about what medicine is given by the doctor, for what condition, and when it needs to be taken in what dose. This information given by the doctor is called Prescription. The patients should be familiar with the medicine prescription, and the details about the medicine before purchasing it and using it. Some medications need not be prescribed by healthcare practitioners and can be purchased and used without prescription by the patients; these are called over-the-counter medications. Read the drug prescription information of Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream before taking it.

Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream uses

1 INDICATIONS AND USAGE

Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is a combination of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.

1.1 Indication

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is a combination of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream (a corticosteroid), hydroquinone (a melanin synthesis inhibitor), and tretinoin (a retinoid) that is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.

1.2 Limitations of Use

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream, some patients may be managed with other treatments instead of triple therapy with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream. Melasma usually recurs upon discontinuation of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream.
The safety and efficacy of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in patients of Fitzpatrick Skin Types V and VI have not been studied. Excessive bleaching resulting in undesirable cosmetic effect in patients with darker skin cannot be excluded.
The safety and efficacy of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.
Because pregnant and lactating women were excluded from, and women of childbearing potential had to use birth control measures in the clinical trials, the safety and efficacy of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in pregnant women and nursing mothers have not been established [see Use in Specific Populations (8.1, 8.3)].
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2 DOSAGE AND ADMINISTRATION

Apply a thin film of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream to the effected area once daily, at least 30 minutes before bedtime.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin.
Therapy should be discontinued when control is achieved.
During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.01%/4%/0.05%.
Each gram of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains 0.1 mg of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, 40 mg of hydroquinone, and 0.5 mg of tretinoin in a light yellow, hydrophilic cream base.
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4 CONTRAINDICATIONS

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. If anaphylaxis, asthma or other clinically significant hypersensitivity reactions occur, institute appropriate therapy and discontinue fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream. Allergic contact dermatitis may also occur [see Warnings and Precautions 5.4].

5.2 Exogenous Ochronosis

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of therapy. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.

5.3 Effects on Endocrine System

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains the corticosteroid fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on treatment. If HPA axis suppression is noted, the use of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.
The ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression.

5.4 Cutaneous Reactions

Cutaneous hypersensitivity to the active ingredients of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream or its components.
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
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6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the controlled clinical trials, adverse events were monitored in the 161 subjects who used fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema, desquamation, burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows:
In an open-label trial, subjects who had cumulative treatment of melasma with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.
The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
Most common adverse reactions (incidence > 5%) are erythema, desquamation, burning, dryness, pruritus, and acne. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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8 USE IN SPECIFIC POPULATIONS

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains the teratogen, tretinoin, which may cause embryofetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.
In clinical trials involving fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 13 women became pregnant during treatment with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream. Most of the pregnancy outcomes are unknown. Three women gave birth to apparently healthy babies. One pregnancy was terminated prematurely, and another ended in miscarriage.
In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogenesis due to topical exposure to fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy.
Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
- In a dermal application study using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in pregnant rabbits, there was an increase in the number of in utero deaths and a decrease in fetal weights in litters from dams treated topically with the drug product.
- In a dermal application study in pregnant rats treated with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream during organogenesis there was evidence of teratogenicity of the type expected with tretinoin. These morphological alterations included cleft palate, protruding tongue, open eyes, umbilical hernia, and retinal folding or dysplasia.
- In a dermal application study on the gestational and postnatal effects of a 10-fold dilution of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in rats, an increase in the number of stillborn pups, lower pup body weights, and delay in preputial separation were observed. An increase in overall activity was seen in some treated litters at postnatal day 22 and in all treated litters at five weeks, a pattern consistent with effects previously noted in animals exposed in utero with retinoic acids. No adequate study of the late gestational and postnatal effects of the full-strength fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream has been performed.
- It is difficult to interpret these animal studies on teratogenicity with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream, because the availability of the dermal applications in these studies could not be assured, and comparison with clinical dosing is not possible.

8.3 Nursing Mothers

Corticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream.

8.4 Pediatric use

Safety and effectiveness of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
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11 DESCRIPTION

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light.
The chemical name for fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream is: (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.
The molecular formula is C24H30F2O6 and molecular weight is 452.50.
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream has the following structural formula:
Hydroquinone is a melanin synthesis inhibitor. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air.
The chemical name for hydroquinone is: 1,4-benzenediol.
The molecular formula is C6H6O2 and molecular weight is 110.11.
Hydroquinone has the following structural formula:
Tretinoin, a retinoid, is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture.
The chemical name for tretinoin is: (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
The molecular formula is C20H28O2 and molecular weight is 300.44.
Tretinoin has the following structural formula:
Each gram of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream contains Active: fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
fluocinolone-mol hydro-mol tretinoin
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of the active ingredients in fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in the treatment of melasma is unknown.

12.3 Pharmacokinetics

Percutaneous absorption of unchanged tretinoin, hydroquinone and fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream into the systemic circulation of two groups of healthy volunteers (Total N=59) was found to be minimal following 8 weeks of daily application of 1g (Group I, n=45) or 6g (Group II, n=14) of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream.
For tretinoin quantifiable plasma concentrations were obtained in 57.78% (26 out of 45) of Group I and 57.14% (8 out of 14) of Group II subjects. The exposure to tretinoin as reflected by the Cmax values ranged from 2.01 to 5.34 ng/mL (Group I) and 2.0 to 4.99 ng/mL (Group II). Thus, daily application of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream resulted in a minimal increase of normal endogenous levels of tretinoin. The circulating tretinoin levels represent only a portion of total tretinoin-associated retinoids, which would include metabolites of tretinoin and that sequestered into peripheral tissues.
For hydroquinone, quantifiable plasma concentrations were obtained in 18% (8 out of 44) Group I subjects. The exposure to hydroquinone, as reflected by the Cmax values, ranged from 25.55 to 86.52 ng/mL. All Group II subjects (6g dose) had post-dose plasma hydroquinone concentrations below the quantitation limit. For fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, Groups I and II subjects had all post-dose plasma concentrations below quantitation limit.
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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

When fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, and 150% of the concentrations in the clinical formulation of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream were applied topically to male and female CD-1 mice for up to 24 months at dosages approximating up to 50, 19,000, and 250 µg/kg/day, respectively (corresponding to dosages of 150, 57,000, and 750 μg/m2/day, respectively), no statistically significant changes in tumor incidence were observed.
When fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 25%, 50%, and 100% of the concentrations in the clinical formulation of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream were applied topically to male and female SD rats for up to 24 months at dosages approximating up to 10, 4000, and 50 µg/kg/day, respectively (corresponding to dosages of 60, 24,000, and 300 μg/m2/day, respectively), statistically significant increases in the incidences of islet cell adenomas and combined islet cell adenomas and carcinomas of the pancreas in both males and females were observed. The clinical relevance of these findings is unknown.
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. Additional information regarding the genetic toxicity potential of tretinoin and of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream is not available.
A dermal reproductive fertility study was conducted in SD rats using a 10-fold dilution of the clinical formulation. No effect was seen on the traditional parameters used to assess fertility, although prolongation of estrus was observed in some females, and there was a trend towards an increase in pre-and post-implantation loss that was not statistically significant. No adequate study of fertility and early embryonic toxicity of the full-strength drug product has been performed. In a six-month study in minipigs, small testes and severe hypospermia were found when males were treated topically with the full strength drug product.
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14 CLINICAL STUDIES

Two adequate and well-controlled efficacy and safety trials were conducted in 641 subjects between the ages of 21 to 75 years, having Fitzpatrick Skin types I-IV and moderate to severe melasma of the face. fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream 0.01% (FA) + tretinoin 0.05% (RA); (3) fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream. Subjects were instructed to apply their study medication each night, after washing their face with a mild soapless cleanser, for 8 weeks. Instructions were given to apply a thin layer of study medication to the hyperpigmented lesion, making sure to cover the entire lesion including the outside borders extending to the normal pigmented skin. Subjects were provided a mild moisturizer for use as needed. A sunscreen with SPF 30 was also provided with instructions for daily use. Protective clothing and avoidance of sunlight exposure to the face was recommended.
Subjects were evaluated for melasma severity at Baseline and at Weeks 1, 2, 4, and 8 of treatment. Primary efficacy was based on the proportion of subjects who had an investigators’ assessment of treatment success, defined as the clearing of melasma at the end of the eight-week treatment period. The majority of subjects enrolled in the two trials were white (approximately 66%) and female (approximately 98%). fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream was demonstrated to be significantly more effective than any of the other combinations of the active ingredients.
PRIMARY EFFICACY ANALYSIS:
p-value is from Cochran-Mantel-Haenszel chi-square statistics controlling for pooled investigator and comparing fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream to the other treatment groups.
In the Investigators’ assessment of melasma severity at Day 56 of treatment, the following table shows the clinical improvement profile for all subjects treated with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream based on severity of their melasma at the start of treatment.
Assessment Scale: Cleared (melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation); Mild (slightly darker than the surrounding normal skin); Moderate (moderately darker than the surrounding normal skin); Severe (markedly darker than the surrounding normal skin).
Subjects experienced improvement of their melasma with the use of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream, 4 of them did not maintain the remission after an additional 4 weeks of treatment.
After 8 weeks of treatment with the trial drug, subjects entered into an open-label extension period in which fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream was given on an as-needed basis for the treatment of melasma. The remission periods appeared to shorten between progressive courses of treatment. Additionally, few subjects maintained complete clearing of melasma (approximately 1 to 2%).
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16 HOW SUPPLIED/STORAGE AND HANDLING

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is light yellow in color, and supplied in 30 g aluminum tubes, NDC 0299-5950-30.
Storage: Keep tightly closed. Store in a refrigerator, 2° - 8°C (36° - 46°F). Protect from freezing.
See FDA-approved patient labeling (Patient Information)
Inform patients of the following:

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Manufactured by:
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
P51400-1
or
Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada
P52091-2
PATIENT INFORMATION
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream® (try-LOOM-ah)
(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)
Cream
Important information: fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is for use on skin only. Do not use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream in your mouth, eyes, or vagina.
What is the most important information I should know about fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream may cause birth defects or death of the baby if used during pregnancy. The risk of birth defects or death of the baby may be greater if fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is used during the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.
If you become pregnant while using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream, tell your doctor right away.
What is fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is a prescription medicine used for the short-term treatment of moderate to severe melasma of the face, in combination with sun avoidance and the use of sunscreens.
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is not for continuous treatment of melasma.
It is not known if fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is safe and effective in children.
It is not known if fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is safe and effective in people with dark brown to black skin color.
It is not known if fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is safe and effective in the treatment of dark spots (hyperpigmentation) of the skin caused by conditions other than melasma of the face.
It is not known if fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream is safe and effective in females who are pregnant or who are breastfeeding. See "What is the most important information I should know about fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream? and What should I tell my doctor before using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?"
Who should not use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
Do not use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream if you are allergic to it or any of the ingredients in fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream. See the end of this leaflet for a complete list of ingredients in fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream.
What should I tell my doctor before using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
Before you use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements and skin products that you use.
How should I use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?

What should I avoid while using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?

What are the possible side effects of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream may cause serious side effects, including:
- allergic reactions. fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream may cause allergic reactions that can be life threatening. Stop using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream and call your doctor or get medical help right away if you get any of the following symptoms:

- change in skin color. One of the medicines in fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream can cause a blue-black darkening of your skin. Stop using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream and tell you doctor if you develop a blue-black darkening of your skin.
- fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream can pass through your skin. Too much fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check for adrenal gland problems.
- skin irritation. Stop using fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream and call your doctor if you have:

The most common side effects of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream include:

Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.
How should I store fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?

General information about the safe and effective use of fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream for a condition for which it was not prescribed. Do not give fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream that is written for health professionals.
What are the ingredients in fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream Cream?
Active ingredients: fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, hydroquinone, and tretinoin
Inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol
This Patient Information has been approved by the U.S. Food and Drug Administration.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Manufactured by:
Hill Dermaceuticals, Inc.
Sanford, FL 32773 USA
or
Manufactured by:
G Production Inc.
Baie dUrfé, QC, H9X 3S4 Canada
Made in Canada
Revised: March 2014

fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream® (fluocinolone acetonide, hydroquinone, tretinoin) cream, 0.01%/4%/0.05%
MUST BE REFRIGERATED
NDC 0299-5950-30
Rx Only
NET WT. 30 g
GALDERMA
Lot No.: Exp. Date:
For Topical Use Only. Not for Ophthalmic Use.
Usual dosage: Apply a thin film to affected areas once daily at night. See package insert for complete prescribing information.
Each gram contains: Active: fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
Storage: Store in a refrigerator, 2° to 8°C (36° to 46°F). Protect from freezing.
www.triluma.com
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Galderma is a registered trademark.
P51399-2
MUST BE REFRIGERATED
p51399-2-tri-luma-30g-crm-crtn

Select the most affordable brand or generic drug

Generic drug is the basic drug with an active substance in it, and the name of the generic drug is same as active substance most of the times. Like Acetaminophen/Paracetemol is Generic name and it has different brand names like Tylenol, Acimol, Crocin, Calpol etc. All these Brand names contain the same Paracetemol, but the medications are manufactured by different companies, so the different brand names. Generic drug is always cheaper and affordable, and it can be replaced in place of brand name drug prescribed by the healthcare practitioner. The Generic medicine has same properties as branded medicine in terms of uses, indications, doses, side effects, so no need to worry on that. Just select the most affordable generic or branded medicine.

StrengthQuantityPrice, USDCountry
0 .01/4/0.05%1 x30gcream$198.00Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
0 .01/4/0.05%1 x30gcream$199.00Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
NoStrengthProvided30 cream$115.00USA
NoStrengthProvided30 grams$115.00USA
Tri-Luma 15 g $400.00
Tri-Luma cream 15 g x 1's $78.34Galderma
0 .01/4/0.05%1 x30gcream$198.00Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
0 .01/4/0.05%1 x30gcream$199.00Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
NoStrengthProvided30 cream$115.00USA
NoStrengthProvided30 grams$115.00USA
Tri-Luma 15 g $400.00
Tri-Luma cream 15 g x 1's $78.34Galderma

References

  1. Dailymed."Fluocinolone acetonide; hydroquinone; tretinoin: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."Tri-luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream [galderma laboratories, l.p.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "Fluocinolone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream - Frequently asked Questions

Can Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream be stopped immediately or do I have to stop the consumption gradually to ween off?

In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.

It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.

Can Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream be taken or consumed while pregnant?

Please visit your doctor for a recommendation as such case requires special attention.

Can Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream be taken for nursing mothers or during breastfeeding?

Kindly explain your state and condition to your doctor and seek medical advice from an expert.

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Reviews

Following the study conducted by gmedication.com on Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream, the result is highlighted below. However, it must be clearly stated that the survey and result is based solely on the perception and impression of visitors and users of the website as well as consumers of Fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream. We, therefore, urge readers not to base their medical judgment strictly on the result of this study but on test/diagnosis duly conducted by a certified medical practitioners or physician.

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The information was verified by Dr. Vishal Pawar, MD Pharmacology