Label: HYDROCORTISONE ANTI-ITCH- hydrocortisone cream

  • NDC Code(s): 52000-022-36, 52000-022-37
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 9, 2020

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

  • 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 use in 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:52000-022-371 in 1 BOX12/09/2020
    1NDC:52000-022-3614 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/09/2020
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-022)