Label: HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 52000-022-38, 52000-022-39
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Hydrocortisone 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of itching associated with minor skin irritations and rashes due to:

    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy, oak, sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • external genital, feminine and anal itching

    Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not usein genital area if you have a vaginal discharge.

    Consult a doctor, for the treatment of diaper rash. Ask a doctor.

  • WHEN USING

    When using this product

    • Avoid contact with eyes
    • Do not use more than directed unless told to do so by a doctor
    • Do not put directly into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor. Rectal bleeding occurs.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    For itching of skin irritation, inflammation, and rashes:

    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: Ask a doctor

    For external anal and genital itching, adults:

    When practical, clean the affected area with mild soap and water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
    Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at 20ºC to 25º C (68ºF to 77º F)
    • Lot No. & Exp. Date: see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    HYDROCORTISONE ANTI-ITCH CREAM

    NET WT 0.5 OZ. (14 g)

    label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-022-391 in 1 BOX12/09/2020
    1NDC:52000-022-3814 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/09/2020
    Labeler - Universal Distribution Center LLC (019180459)