Adapalene and Benzoyl Peroxide (Page 5 of 5)

Package/Label Display Panel

45 gram Pump Carton

NDC 68462-301-47Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%

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ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-301
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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CYCLOMETHICONE
DOCUSATE SODIUM
EDETATE DISODIUM
GLYCERIN
PROPYLENE GLYCOL
POLOXAMER 124
WATER
SORBITAN MONOOLEATE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-301-55 45 g in 1 TUBE None
2 NDC:68462-301-47 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
2 45 g in 1 BOTTLE, PUMP This package is contained within the CARTON (68462-301-47)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208108 11/08/2019
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 MANUFACTURE (68462-301), ANALYSIS (68462-301)

Revised: 11/2020 Glenmark Pharmaceuticals Inc., USA

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