Label: DESONIDE ointment

  • NDC Code(s): 71589-005-15, 71589-005-60
  • Packager: Aleor Dermaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 2, 2019

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  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    TUBE LABEL

    Rx Only

    NDC 71589-005-15

    Desonide Ointment, 0.05%

    FOR EXTERNAL USE ONLY

    NOT FOR OPHTHALMIC USE

    NET WT 15 grams

    Image

    CARTON LABEL

    Rx Only

    NDC 71589-005-15

    Desonide Ointment, 0.05%

    FOR EXTERNAL USE ONLY

    NOT FOR OPHTHALMIC USE

    NET WT 15 grams

    Image
  • INGREDIENTS AND APPEARANCE
    DESONIDE 
    desonide ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71589-005
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71589-005-151 in 1 CARTON11/02/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71589-005-601 in 1 CARTON11/02/2019
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21247311/02/2019
    Labeler - Aleor Dermaceuticals Limited (871411532)
    Registrant - Aleor Dermaceuticals Limited (871411532)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aleor Dermaceuticals Limited871411532MANUFACTURE(71589-005) , ANALYSIS(71589-005)