, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. The acute oral toxicity of DIFFERIN Gel in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
DOSAGE AND ADMINISTRATION:
DIFFERIN Gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.
During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.
HOW SUPPLIED:
DIFFERIN (adapalene gel) Gel, 0.1% is supplied in the following size:
45 g laminate tube - NDC 0299-5910-45
Storage:
Store at controlled room temperature 68° - 77°F (20° - 25°C), excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Mfd. by:
G Production Inc.
Baie d’Urfe, QC, H9X 3S4 Canada
Made in Canada.
GALDERMA is a registered trademark.
P50045-1
Revised: April 2011
PACKAGE LABEL
p50053-3-differin-gel-0-1-45g-ctn
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
DIFFERIN
adapalene gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5910
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLOXAMER 182 (UNII: JX0HIX6OAG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0299-5910-45 1 in 1 CARTON
1 45
