Label: MAXIMUM STRENGTH 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 03/13

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  • Active Ingredient

    Hydrocortisone, USP 1%

    Purpose

    Antipuritic (Anti-Itch)

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  • Uses

    • for the temporary relief of itching associated with minor itching associated with minor skin irritatitions, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
    • for 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


    For external use only.

    Do not use

    • for the treatment of diaper rash. Consult a doctor
    • for external feminine itching if you have a vaginal discharge. Consult a doctor.

    When using this product

    • avoid contact with the eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put this product into rectum by using fingers or any medical device or applicator

    Stop use 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. Do not begin use of any other hydrocortisone product unless you have consulted a doctor
    • rectal bleeding occurs

    Keep out of the 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

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  • Other information

    store at room temperature 15-30C (59-86F)

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  • Inactive Ingredients

    mineral oil, petrolatum

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  • Product Labeling

    For fast relief of itching due to:

    • Eczema and Psoriasis
    • Insect bites
    • Soaps and detergents
    • Poison Ivy and Poison Sumac
    Maximum Strength  Hydrocortisone 1%
    For relief of itching, rashes, and skin irritations


    Hydrocortisone

    Hydrocortisone

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24286-1560
    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
    MINERAL OIL  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24286-1560-1 1 in 1 BOX
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/22/2013
    Labeler - DLC Laboratories, Inc (093351930)
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