Label: CLOBETASOL PROPIONATE cream

  • NDC Code(s): 70771-1442-1, 70771-1442-2, 70771-1442-3, 70771-1442-4
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1442-1

    Clobetasol Propionate Cream USP, 0.05%

    Rx only

    15 g

    Clobetasol Propionate Cream
    Clobetasol Propionate Cream
  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1442
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1442-11 in 1 CARTON01/09/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1442-21 in 1 CARTON01/09/2019
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70771-1442-41 in 1 CARTON01/09/2019
    345 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70771-1442-31 in 1 CARTON01/09/2019
    460 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21107401/09/2019
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited650650802ANALYSIS(70771-1442) , MANUFACTURE(70771-1442)