Label: HYDROCORTISONE- hydrocortisone acetate cream

  • NDC Code(s): 50332-0042-1, 50332-0042-2, 50332-0042-4, 50332-0042-7
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

  • PURPOSE

    Purpose: anti-itch cream

  • INDICATIONS & USAGE

  • WARNINGS

    Warnings: For external use only. Do not get in eyes

    Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

  • DO NOT USE

    Do not use:

    • in the eyes or over large portions of the body
    • for the treatment of diaper rash
    • with any other hydrocortisone product

  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • condition lasts for more than 7 days
    • symptoms clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

    Children under 12 years of age: do not use, ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • PRINCIPAL DISPLAY PANEL

    Hydrocortv24f.jpgHydrocortv24f.jpg

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0042
    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
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0042-110 in 1 BOX, UNIT-DOSE01/01/1974
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0042-710 in 1 BAG01/01/2000
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0042-225 in 1 BOX, UNIT-DOSE01/01/1974
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:50332-0042-4144 in 1 BOX, UNIT-DOSE01/01/1974
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01/01/1974
    Labeler - HART Health (069560969)
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