Label: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel

  • NDC Code(s): 70771-1450-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated August 4, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1450-4

    Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%

    Rx only

    45 g

    Clindamycin and benzoyl paroxide gel
    carton label
  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE 
    clindamycin phosphate and benzoyl peroxide gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE10 mg  in 1 g
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1450-41 in 1 CARTON03/07/2019
    145 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21079403/07/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1450) , MANUFACTURE(70771-1450)
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