DIFFERIN (Page 4 of 4)

PACKAGE LABEL — 45 g PUMP

45-gram-carton-image
(click image for full-size original)

Rx only

NDC 0299-5918-25

Differin® 0.3
(adapalene) Gel, 0.3%

PUMP

FOR TOPICAL USE ONLY

NET WT. 45 g

Galderma

For topical use only. Not for ophthalmic, oral, or intravaginal use.

Usual dosage: apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information.

Each gram contains: adapalene 0.3% (3 mg) in an aqueous gel consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing.

See carton closure for lot number and expiration date.

Marketed by:GALDERMA LABORATORIES, L.P.
Fort Worth, TX 76177 USA
Made in Canada
All trademarks are the property of their respective owners.
www.differin.com P51959-5

PACKAGE LABEL — 45 g Tube

45g-tube-carton
(click image for full-size original)

DIFFERIN (adapalene) gel, 0.3%
GEL
For topical use only
NET WT. 45g
NDC 0299-5918-45
Rx only
Galderma

For topical use only. Not for ophthalmic, oral, or intravaginal use.
Usual dosage: Apply a thin film once a day at nighttime to affected areas. See package insert for complete prescribing information.
Each gram contains: adapalene 0.3% (3 mg) in a topical aqueous gel consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May also contain hydrochloric acid for pH adjustment.
Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C).
Protect from freezing.
See carton closure for lot number and expiration date.
Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Made in Canada
GALDERMA is a registered trademark.
www.differin.com
P51241-3

DIFFERIN adapalene gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5918
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Adapalene (ADAPALENE) Adapalene 3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Carbomer Homopolymer Type C
Edetate Disodium
Methylparaben
Propylene Glycol
Water
Sodium Hydroxide
Hydrochloric Acid
Poloxamer 124
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5918-45 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0299-5918-45)
2 NDC:0299-5918-25 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5918-25)
3 NDC:0299-5918-15 1 TUBE in 1 CARTON contains a TUBE
3 15 g in 1 TUBE This package is contained within the CARTON (0299-5918-15)
4 NDC:0299-5918-02 2 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021753 09/15/2009
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 manufacture (0299-5918)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5918)

Revised: 08/2022 Galderma Laboratories, L.P.

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