Label: DESONIDE cream

  • NDC Code(s): 70771-1381-1, 70771-1381-3
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 24, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1381-1

    Desonide cream, 0.05%

    15 g

    Rx only

    Desonide Cream
    Desonide Cream
  • INGREDIENTS AND APPEARANCE
    DESONIDE 
    desonide cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DESONIDE (UNII: J280872D1O) (DESONIDE - UNII:J280872D1O) DESONIDE0.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1381-11 in 1 CARTON11/25/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70771-1381-31 in 1 CARTON11/25/2019
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21019811/25/2019
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited650650802ANALYSIS(70771-1381) , MANUFACTURE(70771-1381)