Label: HYDROCORTISONE ANTI-ITCH PLUS- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Hydrocortisone 1%

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  • Purpose

    Anti-itch

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  • Uses

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

    For external use only

    Do not use

    • in the genital area if you have a vaginal discharge. Consult a doctor.
    • for the treatment of diaper rash. Consult a doctor.

    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 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. If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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 of age: ask a doctor
    • for external anal and genital itching, adults:
      • when practical, clean the affected area with mild soap and warm 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
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  • Other information

    • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
    • Store at 20° to 25°C (68° to 77°F)
    • See carton or tube crimp for lot number and expiration date
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  • Inactive Ingredients

    aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

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  • Questions?

    Call 1-888-287-1915

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Wal-Mart Stores, Inc.,
    Bentonville, AR 72716

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  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    NDC 49035-732-20

    equate

    Compare to
    Maximum
    Strength
    Cortizone•10®
    Plus Active
    Ingredient*

    Maximum Strength

    Anti-Itch Plus

    1% Hydrocortisone
    Anti-Itch Cream

    With 12 Healing Moisturizers
    Including Aloe and
    Vitamins A, D & E

    Soothes and relieves:

    • Dry, itchy skin
    • Skin irritation and rashes
    • Eczema and psoriasis

    NET WT 2 OZ (60 g)

    Principal Display Panel - 60 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE ANTI-ITCH PLUS 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-732
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    chamomile flower oil  
    citric acid monohydrate  
    corn oil  
    glycerin  
    isopropyl palmitate  
    maltodextrin  
    methylparaben  
    mineral oil  
    paraffin  
    petrolatum  
    propylene glycol  
    propylparaben  
    water  
    stearyl alcohol  
    vitamin A  
    Cholecalciferol  
    .Alpha.-Tocopherol  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-732-20 1 in 1 CARTON
    1 60 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/01/2010
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49035-732)
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