Label: HYDROCORTISONE WITH ALOE- hydrocortisone cream

  • NDC Code(s): 41250-408-02, 41250-408-03
  • Packager: Meijer Distribution Inc
  • 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 02/13

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 cream

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  • Uses

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

    For external use only

    Do not use

    • in the eyes
    • by putting this product into the rectum by using fingers or any mechanical device or applicator

    Ask a doctor before use if you have

    • a vaginal discharge
    • rectal bleeding
    • diaper rash

    When using this product consult a doctor before exceeding recommended dosage

    Stop use and ask a doctor if

    • condition gets worse
    • condition persists for more than 7 days
    • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    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: do not use. consult a doctor

    For external anal itching:

    • Adults: when practical, cleanse 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 application of this product

    Children under 12 years of age: consult 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 room temperature
    • 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, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, stearyl alcohol

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    2929 WALKER AVE NW
    GRAND RAPIDS, MI 49544

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  • PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

    meijer

    Compare to Cortizone•10® active ingredient*

    Maximum Strength

    With Aloe

    Anti-Itch Relief
    1% Hydrocortisone Cream
    Antipruritic

    NET WT 2 0Z (60 g)

    Principal Display Panel - 60 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE   WITH ALOE
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-408
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    cetostearyl alcohol  
    sodium lauryl sulfate  
    sodium cetostearyl sulfate  
    citric acid monohydrate  
    glycerin  
    glyceryl monostearate  
    methylparaben  
    mineral oil  
    paraffin  
    propylparaben  
    water  
    stearyl alcohol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-408-02 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    2 NDC:41250-408-03 1 in 1 CARTON
    2 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 08/23/1995
    Labeler - Meijer Distribution Inc (006959555)
    Registrant - Taro Phamaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Phamaceuticals Inc. 206263295 MANUFACTURE(41250-408)
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