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
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!