Adapalene and Benzoyl Peroxide (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton

Rx Only

NDC 45802-846 -01

Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

Pump

For Topical Use Only

NET WT 45 g

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The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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ADAPALENE AND BENZOYL PEROXIDE
adapalene and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-846
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
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM
EDETATE DISODIUM
GLYCERIN
ISOHEXADECANE
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SORBITAN MONOOLEATE
POLOXAMER 124
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-846-01 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (45802-846-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205033 01/24/2018
Labeler — Perrigo New York Inc (078846912)

Revised: 02/2019 Perrigo New York Inc

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