Adapalene and Benzoyl Peroxide: Package Insert and Label Information

ADAPALENE AND BENZOYL PEROXIDE — adapalene and benzoyl peroxide gel
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adapalene and benzoyl peroxide gel 0.3%/2.5%

NDC 70771-1716-4

45 g

Rx only

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carton label
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ADAPALENE AND BENZOYL PEROXIDE
adapalene and benzoyl peroxide gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1716
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADAPALENE (ADAPALENE) ADAPALENE 3 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
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)
SORBITAN MONOOLEATE
WATER
Product Characteristics
Color WHITE (white to very pale yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1716-4 1 BOTTLE, PUMP in 1 BOTTLE, PUMP contains a BOTTLE, PUMP
1 45 g in 1 BOTTLE, PUMP This package is contained within the BOTTLE, PUMP (70771-1716-4)
2 NDC:70771-1716-3 1 BOTTLE, PUMP in 1 BOTTLE, PUMP contains a BOTTLE, PUMP
2 60 g in 1 BOTTLE, PUMP This package is contained within the BOTTLE, PUMP (70771-1716-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214553 06/06/2022
Labeler — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 650650802 ANALYSIS (70771-1716), MANUFACTURE (70771-1716)

Revised: 06/2022 Zydus Lifesciences Limited

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