EPIDUO (Page 4 of 4)

PACKAGE LABEL — 45 g TUBE

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

Epiduo®
(adapalene and benzoyl peroxide)
Gel 0.1% / 2.5%
FOR TOPICAL USE ONLY
NET WT. 45 g
NDC 0299-5908-45
Rx only

GALDERMA

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

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

Each gram contains Active: adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous gel consisting of Inactive: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° and 86°F (15° and 30°C).
See carton closure for lot number and expiration date.

Marketed by:
GALDERMA LABORATORIES, L.P.
14501 North Freeway, Fort Worth, TX 76177 USA
www.epiduo.com
P51359-3
Manufactured by:
G Production Inc.
Baie d’Urfé, QC, H9X 3S4 Canada
Made in Canada.
Galderma is a registered trademark.

EPIDUO adapalene and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0299-5908
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (ADAPALENE) ADAPALENE 1 mg in 1 g
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
docusate sodium
edetate disodium
glycerin
Isohexadecane
poloxamer 124
polysorbate 80
propylene glycol
Water
Sorbitan Monooleate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0299-5908-45 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (0299-5908-45)
2 NDC:0299-5908-25 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (0299-5908-25)
3 NDC:0299-5908-02 2 g in 1 TUBE None
4 NDC:0299-5908-00 1 TUBE in 1 BLISTER PACK contains a TUBE
4 2 g in 1 TUBE This package is contained within the BLISTER PACK (0299-5908-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022320 12/08/2008
Labeler — Galderma Laboratories, L.P. (047350186)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (0299-5908)

Revised: 02/2018 Galderma Laboratories, L.P.

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