ADAPALENE (Page 4 of 4)

PACKAGE LABEL — 45g Tube

PRASCO NDC 66993-884-45

Rx Only

Adapalene Gel, 0.3%

Net Wt. 45 g For topical use only

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: Active: adapalene 0.3% (3 mg) in a topical aqueous gel consisting of Inactive: 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° — 77°F (20° — 25°C) with excursions permitted between 59° — 86°F (15° — 30°C). Protect from freezing.

See carton closure for lot number and expiration date.

Distributed by:
Prasco Laboratories
Mason, OH 45040 USA

Manufactured by:
G Production Inc.
Baie d’Urfe´, QC, H9X 3S4 Canada
Made in Canada
Rev. 02/2017
P52326-1

PACKAGE LABEL — 45 gram PUMP

NDC 66993-884-48
Rx only
PRASCO

Adapalene Gel, 0.3%
PUMP
FOR TOPICAL USE ONLY
NET WT. 45 g

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 contain hydrochloric acid for pH adjustment.
Storage: Store at controlled room temperature 68°- 77°F (20° — 25°C) with excursions permitted between 59° — 86°F (15° — 30°C). Protect from freezing.
See carton closure for lot number and expiration date.

Marketed by:
Prasco Laboratories
Mason, OH 45040 USA
Manufactured by:
G Production Inc.
Baie d’Urfe´, QC, H9X 3S4 Canada
Made in Canada P52322-1

ADAPALENE adapalene gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-884 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:66993-884-45 1 TUBE in 1 CARTON contains a TUBE 1 45 g in 1 TUBE This package is contained within the CARTON (66993-884-45) 2 NDC:66993-884-48 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP 2 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (66993-884-48)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA021753 01/01/2014

Labeler — Prasco Laboratories (065969375)

Registrant — Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Operations
G Production Inc.		251676961	manufacture (66993-884)

Revised: 02/2018 Prasco Laboratories