Label: UEC MEDICAL ANTI-ITCH- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

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 April 5, 2018

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Hydrocortisone 1%......................................................Anti-itch

  • PURPOSE

    Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • insect bites
    • poison ivy, oak, or sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • temporarily relieves external anal and genital itching
    • other uses of this product should be under advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in the 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 than7 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.

  • INDICATIONS & USAGE

    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 tissues 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
  • STORAGE AND HANDLING

    Other information

    • store at 20° to 25°C (68° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetamacrogol 1000, cetostearyl alcohol, chlorocresol, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Untied Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    10393

  • PRINCIPAL DISPLAY PANEL

    10397

  • INGREDIENTS AND APPEARANCE
    UEC MEDICAL ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-393
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-393-2020 in 1 BOX04/04/2016
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:65923-393-44144 in 1 BOX04/04/2016
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/04/2016
    Labeler - United Exchange Corp. (840130579)
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