Label: 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

    First Aid

    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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
    • 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

    Ask a doctor before use:

    • if you have a vaginal discharge (for external feminine itching)
    • for external itching, do not exceed the recommended daily dosage, or if bleeding occurs
    • if condition worses or if symptoms persist for more than 7 days or clear up and occur again within a few days

    When using this product

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

    Do not use:

    • with 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:

    • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
    • children under 2 years of age: do not use, consult a doctor
    • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • children under 12 years of age: for external anal itching, consult a doctor
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  • Other Information:

    • store at room temperature (do not freeze)
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients:

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

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  • Questions or Comments? 1-800-234-1464
  • PRINCIPAL DISPLAY PANEL – 144 count box

    mooremedical
    Supporting Health & Care

    Reorder No. 82464
    UPN# 0-0607415-82464-3

    MooreBrand
    Hydrocortisone
    Cream 1%
    144 Packets
    Each Packet Net. Wt. 1.0gm

    Temporary relief of itching
    associated with minor skin irritation,
    inflammation and rashes.

    To reorder:
    Call: 1-800-234-1464
    Fax: 1-800-944-6667
    Online:
    www.mooremedical.com

    PRINCIPAL DISPLAY PANEL – 144 count box
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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55670-800
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    alcohol  
    methylparaben  
    mineral oil  
    paraffin  
    petrolatum  
    propylparaben  
    water  
    white wax  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55670-800-01 144 in 1 BOX
    1 1.0 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/12/2012
    Labeler - Moore Medical LLC (051420107)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(55670-800)
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