Label: DESOXIMETASONE cream

  • NDC Code(s): 70771-1437-0, 70771-1437-1, 70771-1437-3
  • 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

    NDC 70771-1437-1 in tube of 15gm

    Desoximetasone Cream USP, 0.25%

    Rx only

    15 gm

    Desoximetasone Cream USP, 0.25%
    Desoximetasone Cream USP, 0.25%
  • INGREDIENTS AND APPEARANCE
    DESOXIMETASONE 
    desoximetasone cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1437
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1437-11 in 1 CARTON02/12/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1437-31 in 1 CARTON02/12/2019
    260 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70771-1437-01 in 1 CARTON02/12/2019
    3100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20562002/12/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (650650802)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1437) , MANUFACTURE(70771-1437)