DRUGS & SUPPLEMENTS

Dermalar

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Dermalar uses


1 INDICATIONS AND USAGE

Dermalar Cream is a combination of Dermalar acetonide, 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

Dermalar Cream is a combination of Dermalar acetonide (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

Dermalar Cream is NOT indicated for the maintenance treatment of melasma. After achieving control with Dermalar Cream, some patients may be managed with other treatments instead of triple therapy with Dermalar Cream. Melasma usually recurs upon discontinuation of Dermalar Cream.

The safety and efficacy of Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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.

Dermalar Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

  • Apply a thin film to the affected area once daily, at least 30 minutes before bedtime. (2)
  • During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. (2)

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.01%/4%/0.05%.

Each gram of Dermalar Cream contains 0.1 mg of Dermalar acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin in a light yellow, hydrophilic cream base.

  • Cream, 0.01%/4%/0.05%. Each gram of Dermalar Cream contains 0.1 mg of Dermalar acetonide, 40 mg of hydroquinone, and 0.5 mg of tretinoin. (3)

4 CONTRAINDICATIONS

Dermalar Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components.

  • Dermalar Cream is contraindicated in individuals with a history of hypersensitivity to this product or any of its components. (4)
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5 WARNINGS AND PRECAUTIONS

  • Dermalar Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Dermalar.
  • Dermalar 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. (5.2)

5.1 Hypersensitivity

Dermalar 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 Dermalar. Allergic contact dermatitis may also occur [see Warnings and Precautions 5.4].

5.2 Exogenous Ochronosis

Dermalar 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

Dermalar Cream contains the corticosteroid Dermalar acetonide. 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 Dermalar 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 Dermalar 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 Dermalar Cream or its components.

Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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.

table-1

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8 USE IN SPECIFIC POPULATIONS

Dermalar Cream contains the teratogen, tretinoin, which may cause embryofetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. Dermalar 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. Dermalar Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermalar Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.

In clinical trials involving Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar 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 Dermalar Cream has been performed.

- It is difficult to interpret these animal studies on teratogenicity with Dermalar 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 Dermalar Cream could result in sufficient systemic absorption to produce detectable quantities of Dermalar acetonide, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when Dermalar Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and Dermalar Cream.

8.4 Pediatric use

Safety and effectiveness of Dermalar Cream in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Dermalar 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.

11 DESCRIPTION

Dermalar (fluocinolone acetonide, hydroquinone, and tretinoin) Cream, 0.01%/4%/0.05% contains Dermalar acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a light yellow, hydrophilic cream base for topical application.

Dermalar acetonide is a synthetic fluorinated corticosteroid. It is a white crystalline powder that is odorless and stable in light.

The chemical name for Dermalar acetonide 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.

Dermalar acetonide 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 Dermalar Cream contains Active: Dermalar acetonide 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

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of the active ingredients in Dermalar Cream in the treatment of melasma is unknown.

12.3 Pharmacokinetics

Percutaneous absorption of unchanged tretinoin, hydroquinone and Dermalar acetonide 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 Dermalar 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 Dermalar 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 Dermalar acetonide, Groups I and II subjects had all post-dose plasma concentrations below quantitation limit.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

When Dermalar acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 50%, 100%, and 150% of the concentrations in the clinical formulation of Dermalar 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 Dermalar acetonide, hydroquinone, and tretinoin in fixed combinations equivalent to 10%, 25%, 50%, and 100% of the concentrations in the clinical formulation of Dermalar 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 Dermalar acetonide 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.

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. Dermalar Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) Dermalar acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) Dermalar acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as Dermalar 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%). Dermalar 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 Dermalar 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 Dermalar 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 Dermalar Cream as early as 4 weeks. However, among 7 subjects who had clearing at the end of 4 weeks of treatment with Dermalar 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 Dermalar 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

Dermalar 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:

  • Advise patients to change to non-hormonal forms of birth control, if hormonal methods are used.
  • Use Dermalar Cream as directed by the health care provider and do not use Dermalar Cream for any disorder other than that for which it is prescribed.
  • Avoid exposure to sunlight, sunlamp, or ultraviolet light. Patients who are consistently exposed to sunlight or skin irritants either through their work environment or habits should exercise particular caution. Use sunscreen and protective covering (such as the use of a hat) over the treated areas. Sunscreen use is an essential aspect of melasma therapy, as even minimal sunlight sustains melanocytic activity.
  • Weather extremes, such as heat or cold, may be irritating to patients treated with Dermalar Cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.
  • Keep Dermalar Cream away from the eyes, nose, angles of the mouth, or open wounds because these areas are more sensitive to the irritant effect. If local irritation persists or becomes severe, discontinue application of the medication and consult your health care provider. Seek medical attention if you experience allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth.
  • If the medication is applied excessively, marked redness, peeling, or discomfort may occur.
  • Wash your hands after each application.

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

Dermalar® (try-LOOM-ah)

(fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05%)

Cream

Important information: Dermalar Cream is for use on skin only. Do not use Dermalar Cream in your mouth, eyes, or vagina.

What is the most important information I should know about Dermalar Cream?

Dermalar 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 Dermalar 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 Dermalar Cream, tell your doctor right away.

What is Dermalar Cream?

Dermalar 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.

Dermalar Cream is not for continuous treatment of melasma.

It is not known if Dermalar Cream is safe and effective in children.

It is not known if Dermalar Cream is safe and effective in people with dark brown to black skin color.

It is not known if Dermalar 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 Dermalar 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 Dermalar Cream? and What should I tell my doctor before using Dermalar Cream?"

Who should not use Dermalar Cream?

Do not use Dermalar Cream if you are allergic to it or any of the ingredients in Dermalar Cream. See the end of this leaflet for a complete list of ingredients in Dermalar Cream.

What should I tell my doctor before using Dermalar Cream?

Before you use Dermalar Cream, tell your doctor if you:

  • are allergic to sulfites
  • have any other medical conditions
  • are pregnant or plan to become pregnant. See " What is the most important information I should know about Dermalar Cream?"
  • are breastfeeding or plan to breastfeed. It is not known if Dermalar Cream passes into your breast milk. You should avoid skin-to-skin contact between areas treated with Dermalar Cream and your baby.

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 Dermalar Cream?

  • Use Dermalar Cream exactly as your doctor tells you to use it.
  • Before you apply Dermalar Cream, gently wash your face with a mild cleanser. Rinse your face and pat your skin dry.
  • Apply Dermalar Cream 1 time a day, at least 30 minutes before bedtime.
  • Apply a thin layer of Dermalar Cream to the affected skin areas. Include about 1/2 inch of normal skin surrounding the affected area.
  • Gently rub Dermalar Cream evenly into your skin.
  • Do not get Dermalar Cream near the corners of your mouth, your nose, your eyes, or open wounds.
  • Do not bandage or cover the treated skin after applying Dermalar Cream.
  • You may use moisturizers and cosmetics during the day.
  • Wash your hands after applying Dermalar Cream.

What should I avoid while using Dermalar Cream?

  • You should avoid sunlight, sunlamps, tanning beds, and ultraviolet light during treatment with Dermalar Cream.
  • Use sunscreen with an SPF (sun protection factor) of 30 or more. If you have to be in the sunlight, wear a wide-brimmed hat or other protective clothing to cover the treated areas.
  • Melasma can get worse with even a small amont of sunlight. You should continue to avoid sunlight, use sunscreen, and wear protective clothing after treatment with Dermalar Cream.
  • Females should avoid the use of hormonal forms of birth control. Hormonal birth control methods can cause your melasma to become worse. Talk to your doctor about other birth control options.
  • Heat and cold weather may irritate skin treated with Dermalar. Talk with your doctor about ways to manage skin irritation.

What are the possible side effects of Dermalar Cream?

Dermalar Cream may cause serious side effects, including:

- allergic reactions. Dermalar Cream may cause allergic reactions that can be life threatening. Stop using Dermalar Cream and call your doctor or get medical help right away if you get any of the following symptoms:

  • swelling of your face, eyes, lips, tongue, or throat
  • trouble breathing
  • severe itching
  • skin rash or hives

- change in skin color. One of the medicines in Dermalar Cream can cause a blue-black darkening of your skin. Stop using Dermalar Cream and tell you doctor if you develop a blue-black darkening of your skin.

- Dermalar Cream can pass through your skin. Too much Dermalar 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 Dermalar Cream and call your doctor if you have:

  • blistering or crusting of your skin
  • severe burning
  • swelling of your skin
  • irritation of your eyes, nose, or mouth

The most common side effects of Dermalar Cream include:

  • redness
  • peeling
  • burning
  • dryness
  • itching
  • acne

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 Dermalar 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 Dermalar Cream?

  • Store Dermalar Cream in a refrigerator, between 36°F to 46°F (2°C to 8 °C).
  • Keep Dermalar Cream tube tightly closed.
  • Do not freeze Dermalar Cream.

General information about the safe and effective use of Dermalar Cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Dermalar Cream for a condition for which it was not prescribed. Do not give Dermalar 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 Dermalar Cream that is written for health professionals.

What are the ingredients in Dermalar Cream?

Active ingredients: Dermalar acetonide, 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


Dermalar® (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: Dermalar acetonide 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

Dermalar pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Dermalar available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Dermalar destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Dermalar Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Dermalar pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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).
  3. "fluocinolone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dermalar?

Depending on the reaction of the Dermalar after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dermalar not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dermalar addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Dermalar, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dermalar consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported price estimates

What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?
The report given by the sDrugs.com website users shows the following figures about several people who felt the medicine Dermalar is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
Visitors%
Expensive1
100.0%

One visitor reported frequency of use

How often in a day do you take the medicine?
Are you taking the Dermalar drug as prescribed by the doctor?

Few medications can be taken 4 times in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Dermalar is mentioned below.
Visitors%
4 times in a day1
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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