Label: CLOBETASOL PROPIONATE lotion

  • NDC Code(s): 70771-1498-6, 70771-1498-7
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 5, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1498-7

    Clobetasol Propionate Lotion, 0.05%

    Rx only

    118 mL

    Front label
    back label
    carton
  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1498
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-6 ISOSTEARATE (UNII: 0E2639OTJY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1498-71 in 1 CARTON04/30/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1498-61 in 1 CARTON04/30/2020
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20524904/30/2020
    Labeler - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1498) , MANUFACTURE(70771-1498)