Label: ADAPALENE AND BENZOYL PEROXIDE gel

  • NDC Code(s): 70771-1716-3, 70771-1716-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 6, 2022

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  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    ADAPALENE AND BENZOYL PEROXIDE 
    adapalene and benzoyl peroxide gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1716
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE3 mg  in 1 g
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITE (white to very pale yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1716-41 in 1 BOTTLE, PUMP06/06/2022
    145 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:70771-1716-31 in 1 BOTTLE, PUMP06/06/2022
    260 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21455306/06/2022
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1716) , MANUFACTURE(70771-1716)
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