Label: CLOBETASOL PROPIONATE ointment

  • NDC Code(s): 70771-1209-1, 70771-1209-2, 70771-1209-3, 70771-1209-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 26, 2024

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1209-1

    Clobetasol Propionate Ointment USP, 0.05%

    Rx only

    15 g

    clobetasole ointment label
  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1209-11 in 1 CARTON03/22/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1209-21 in 1 CARTON03/22/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70771-1209-41 in 1 CARTON03/22/2018
    345 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70771-1209-31 in 1 CARTON03/22/2018
    460 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21019903/22/2018
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1209) , MANUFACTURE(70771-1209)