Label: SUNMARK HYDROCORTISONE- hydrocortisone ointment

  • 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

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  • 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 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
    • avoid contact with the eyes
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop using this product and ask a doctor

    • in case of bleeding
    • 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

    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

    For External Anal Itching Users

    • do not exceed the recommended daily dosage unless directed by a doctor
    • in case of bleeding, consult a doctor promptly
    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • children under 12 years of age: consult a doctor

    Keep 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.

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  • Directions

    • 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
    • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • children under 12 years of age: Do not use, consult a doctor
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  • Other information

    • to open: unscrew cap and pull tab to remove foil seal
    • if seal has been broken, do not use this product. Return product to the store where you bought it
    • store at controlled room temperature 15° – 30°C ( 59°- 86°F)
    • 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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  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

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  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    sunmark

    hydrocortisone ointment 1%

    Antipruritic (Anti-Itch)

    MAXIMUM STRENGTH

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    SUNMARK   HYDROCORTISONE
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-522
    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:49348-522-72 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 - McKesson (177667227)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-522)
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