Label: CLOBETASOL PROPIONATE spray

  • NDC Code(s): 70771-1080-6, 70771-1080-7
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 27, 2024

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    Clobetasol Propinate Spray, 0.05%

    NDC 70771-1080-6

    2 fl. oz. (59 mL)

    Clobetasol Propinate Spray, 0.05%
  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H) CLOBETASOL PROPIONATE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1080-71 in 1 CARTON07/12/2017
    1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1080-61 in 1 CARTON07/12/2017
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20637807/12/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1080) , MANUFACTURE(70771-1080)