Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: DIFFERIN ® (adapalene) Cream, 0.1% is supplied in the following size: 45 g tube – NDC 0299-5915-45 Storage: Store at controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15°-30°C). Protect from freezing. Marketed by: GALDERMA LABORATORIES, L.P. Dallas, Texas 75201 USA Manufactured by: G Production Inc., Baie d'Urfé, QC, H9X 3S4 Canada Made in Canada. All trademarks are the property of their respective owners. P50448-2 Revised: October 2022; Package Differin ® (adapalene) CREAM 0.1% NET WT. 45 g NDC 0299-5915-45 Rx Only GALDERMA For topical use only. Not for opthalmic, oral, or intravaginal use. Store at controlled room temperature 68° to 77°F (20°-25°C), excursions permitted between 59° and 86°F (15°-30°C). Protect from freezing. Usual dosage: Apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information. See carton closure for lot number and expiration date. Contains: adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. Marketed by: GALDERMA LABORATORIES, L.P. Dallas, Texas 75201 USA Made in Canada All trademarks are the property of their respective owners. P50446-5
- HOW SUPPLIED: DIFFERIN ® (adapalene) Cream, 0.1% is supplied in the following size: 45 g tube – NDC 0299-5915-45 Storage: Store at controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15°-30°C). Protect from freezing. Marketed by: GALDERMA LABORATORIES, L.P. Dallas, Texas 75201 USA Manufactured by: G Production Inc., Baie d'Urfé, QC, H9X 3S4 Canada Made in Canada. All trademarks are the property of their respective owners. P50448-2 Revised: October 2022
- Package Differin ® (adapalene) CREAM 0.1% NET WT. 45 g NDC 0299-5915-45 Rx Only GALDERMA For topical use only. Not for opthalmic, oral, or intravaginal use. Store at controlled room temperature 68° to 77°F (20°-25°C), excursions permitted between 59° and 86°F (15°-30°C). Protect from freezing. Usual dosage: Apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information. See carton closure for lot number and expiration date. Contains: adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. Marketed by: GALDERMA LABORATORIES, L.P. Dallas, Texas 75201 USA Made in Canada All trademarks are the property of their respective owners. P50446-5
Overview
DIFFERIN ® (adapalene) Cream, 0.1%, contains adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. p50448-1-chem-struct
Indications & Usage
: DIFFERIN ® Cream is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
: DIFFERIN ® Cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of DIFFERIN ® Cream.
Warnings & Precautions
No warnings available yet.
Contraindications
: DIFFERIN ® Cream should not be administered to individuals who are hypersensitive to adapalene or any of the components in the cream vehicle.
Adverse Reactions
In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used DIFFERIN ® Cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with DIFFERIN ® Cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with DIFFERIN® Cream from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) < 1% (1) Scaling 58% (166) 35% (100) 6% (18) <1% (1) Dryness 48% (136) 42% (121) 9% (26) <1% (2) Pruritus (persistent) 74% (211) 21% (61) 4% (12) <1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2) Other reported local cutaneous adverse events in patients who used DIFFERIN ® Cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with DIFFERIN ® Cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
Drug Interactions
As DIFFERIN ® Cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime rind) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN ® Cream. If these preparations have been used, it is advisable not to start therapy with DIFFERIN ® Cream until the effects of such preparations in the skin have subsided.
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