Adapalene (Page 3 of 3)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL — TUBE

Rx Only

NDC 45802-453 -84

Adapalene Cream, 0.1%

NET WT 45 g
Perrigo®

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

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

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

Contains: adapalene 0.1% in an aqueous cream emulsion consisting of carbomer 934P, cyclomethicone, edetate disodium, glycerin, methyl glucose sesquistearate, methylparaben, PEG-20 methyl glucose sesquistearate, phenoxyethanol, propylparaben, purified water, squalane, and trolamine.

For lot number and expiration date, see crimp on tube or carton panel.

Made in Canada

Manufactured by:

G Production Inc

Baie d’Urfé, QC, H9X 3S4 Canada

Distributed By Perrigo

Allegan, MI 49010 • www.perrigo.com

P51414-1 9A184 RC T4 Rev. 08-17

ADAPALENE
adapalene cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-453
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (ADAPALENE) ADAPALENE 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)
CYCLOMETHICONE
EDETATE DISODIUM
GLYCERIN
METHYLPARABEN
PHENOXYETHANOL
PROPYLPARABEN
WATER
SQUALANE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-453-84 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (45802-453-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020748 10/26/2010
Labeler — Perrigo New York Inc (078846912)
Registrant — Perrigo New York Inc (078846912)
Establishment
Name Address ID/FEI Operations
G Production Inc. 251676961 manufacture (45802-453)

Revised: 10/2017 Perrigo New York Inc

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