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

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ADAPALENE and BENZOYL PEROXIDE topical gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adapalene and benzoyl peroxide gel 0.3%/2.5%

NDC 70771-1716-4

45 g

Rx only

container label

carton label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)	ADAPALENE	3 mg in 1 g
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLOXAMER 124 (UNII: 1S66E28KXA)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (white to very pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1716-4	1 in 1 BOTTLE, PUMP	06/06/2022
1		45 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC:70771-1716-3	1 in 1 BOTTLE, PUMP	06/06/2022
2		60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214553	06/06/2022

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1716) , MANUFACTURE(70771-1716)

Revised: 6/2022

Document Id: c5532beb-3d81-414d-84ed-580b644495ec

Set id: d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5

Version: 1

Effective Time: 20220606

Zydus Lifesciences Limited