Label: DESOXIMETASONE ointment

  • NDC Code(s): 70771-1166-0, 70771-1166-1, 70771-1166-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 17, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Desoximetasone Ointment USP, 0.25%

    NDC – 70771-1166-1 for 15 gm tube

    Desoximetasone oinment, 0.25
  • INGREDIENTS AND APPEARANCE
    DESOXIMETASONE 
    desoximetasone ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1166
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DESOXIMETASONE (UNII: 4E07GXB7AU) (DESOXIMETASONE - UNII:4E07GXB7AU) DESOXIMETASONE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1166-11 in 1 CARTON12/05/2017
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1166-31 in 1 CARTON12/05/2017
    260 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70771-1166-01 in 1 CARTON12/05/2017
    3100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20520612/05/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1166) , MANUFACTURE(70771-1166)