Label: CVS HYDROCORTISONE WITH ALOE - 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 02/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Hydrocortisone 0.5%.................................................................Anti-itch

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  • PURPOSE

    Uses for the temporary relief of itching associated with minor skin irritations, inflammation 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 of this product should be only under the advice and supervision of a doctor
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  • WARNINGS

    Warnings

    • for external use only
    • avoid contact with eyes
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  • STOP USE

    Stop using this product and ask a doctor

    • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • before you begin using any other hydrocortisone product
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  • DO NOT USE

    Do not use this product and ask a doctor

    • if you have a vaginal discharge
    • before treating diaper rash
    • before using on children under 2 years of age
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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

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

    Before using any medication, read all label directions.  Keep this carton.  It contains important information. Close
  • INDICATIONS & USAGE

    Directions

    • for 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
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No. and Exp. Date: see box or see crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Gel, Butylated Hydroxytoluene, Cetanol, Liquid Paraffin, Methylparaben, Polyonyethylene Cetylether, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Monostearate, Stearyl Alcohol

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  • DOSAGE & ADMINISTRATION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    www.cvs.com

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    CVS HYDROCORTISONE WITH ALOE 
    hydrocortisone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-277
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    BUTYLATED HYDROXYTOLUENE  
    MINERAL OIL  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    STEARYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-277-57 1 in 1 CARTON
    1 57 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/31/2013
    Labeler - CVS PHARMACY (062312574)
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