Label: CLOBETASOL PROPIONATE cream

  • NDC Code(s): 71589-006-15, 71589-006-30, 71589-006-45, 71589-006-60
  • Packager: Aleor Dermaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 1, 2020

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  • PRINCIPAL DISPLAY PANEL

    NDC 71589-006-15

    Clobetasol Propionate Cream USP, 0.05%

    For Dermatologic Use Only. Not for Ophthalmic Use.

    Rx only

    15 grams

    Image
  • PRINCIPAL DISPLAY PANEL

    NDC 71589-006-15

    Clobetasol Propionate Cream USP, 0.05%

    For Dermatologic Use Only. Not for Ophthalmic Use.

    Rx only

    15 grams

    Image
  • INGREDIENTS AND APPEARANCE
    CLOBETASOL PROPIONATE 
    clobetasol propionate cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71589-006
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71589-006-151 in 1 CARTON02/01/2020
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71589-006-301 in 1 CARTON02/01/2020
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:71589-006-451 in 1 CARTON02/01/2020
    345 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:71589-006-601 in 1 CARTON02/01/2020
    460 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21329102/01/2020
    Labeler - Aleor Dermaceuticals Limited (871411532)
    Registrant - Aleor Dermaceuticals Limited (871411532)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aleor Dermaceuticals Limited871411532MANUFACTURE(71589-006) , ANALYSIS(71589-006)