Label: AMERICAN SAFETY AND FIRST AID- hydrocortisone acetate cream

  • NDC Code(s): 71927-015-01, 71927-015-03
  • Packager: Orazen Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 15, 2024

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  • Drug Facts

  • Active Ingredient

    Hydrocortisone Acetate 1%

    Purpose

    Anti-Itch Cream

  • Uses

    • for the temporary relief of itching associated with minor irritations and rashes
    • Other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

    Do not use

    for the treatment of diaper rash. Consult a doctor. Complete Warnings See Card or Box

    Keep out of reach of children.

    If swallowed contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older :apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use
  • Inactive Ingredients

    Cetearyl alcohol, Ceteareth-20, Ethylhexyglycerin,Phenoxyethanol, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Water

  • Package Labeling:

    image of pouch label

    image of box label

  • INGREDIENTS AND APPEARANCE
    AMERICAN SAFETY AND FIRST AID 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-015-03144 in 1 BOX10/17/2022
    1NDC:71927-015-010.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/17/2022
    Labeler - Orazen Inc (080916640)
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