Label: TOPCARE  HYDROCORTISONE- hydrocortisone ointment 

  • Label RSS
  • 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 01/13

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 ointment

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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

    Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

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  • QUESTIONS?

    1-888-423-0139
    topcare@topco.com

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    7711 GROSS POINT ROAD
    SKOKIE, IL 60077

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    TopCare®

    MAXIMUM STRENGTH

    Hydrocortisone 1%
    ANTIPRURITIC (ANTI-ITCH) OINTMENT

    NET WT 1 OZ (28.4 g)

    QUALITY GUARANTEED

    COMPARE TO
    CORTIZONEā€¢10®
    active ingredient*

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    TOPCARE   HYDROCORTISONE
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-018
    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
    Medium-chain triglycerides  
    Methylparaben  
    Propylparaben  
    Petrolatum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-018-02 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 10/03/1989
    Labeler - Topco Associates LLC (006935977)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-018)
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