Differin

Unless your doctor tells you otherwise, continue your normal diet.

• Epiduo^® (containing Adapalene, Benzoyl Peroxide)

Only very small amounts of adapalene are absorbed through skin and into the body. However, there are no adequate studies in pregnant women.

It is not known whether adapalene is excreted in breast milk.

Contraindications

Hypersensitivity to adapalene or any of its components

Cautions

Avoid eyes, lips, and mucous membranes

For external use only

Minimize UV light exposure; use sunscreen and protective clothing

Extreme weather (eg, wind, cold) may cause skin irritation

Adverse reaction risk higher during first month of treatment; generally subsides with use

Do not apply product to abrasions or cuts or to eczematous or sunburned skin

Skin irritation: Apply moisturizer, reduce application frequency, or discontinue

Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants, sulfur, resorcinol, salicylic acid)

Discontinue immediately and consult physician if any anaphylactoid/anaphylactic reactions occur

Topical Administration

Apply small (pea-sized) amount sparingly to entire face after cleansing with nonmedicated cleanser

For topical use only; not for ophthalmic, oral, or intravaginal use

Avoid mucous membranes, eyes, and lips

Differin is a prescription medication used to treat acne.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Specific Drugs

Other Topical Preparations

Potential pharmacodynamic interaction (increased skin irritation).1 31 32 Avoid concurrent use of topical preparations with high concentrations of alcohol, menthol, spices, or lime (e.g., lotions, astringents, perfume); irritating cosmetics (e.g., toners, peeling [desquamating] agents); permanent wave solutions; or hair depilatories or waxes.1 31 32 33

Differin® Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of Differin Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.

The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene 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 C28H28O3 and molecular weight is 412.52. Adapalene is represented by the following structural formula:

Use of Differin Gel should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

Differin®(adapalene gel)

GEL

0.1%

NET WT. 45 g

NDC 0299-5910-45

Rx Only

GALDERMA

For External Use Only. Not For Ophthalmic Use. Store at controlled room temperature 68° to 77°F (20°-25°C) with excursions permitted between 59° - 86°F (15°-30°C). Usual dosage: Apply a thin film once a day to affected areas after washing in the evening before retiring. See package insert for complete prescribing information. See carton closure for lot number and expiration date.

Each gram contains: adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid to adjust pH.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.

GALDERMA is a registered trademark.
P50053-3 www.Differin.com