Label: HYDROCORTISONE  - hydrocortisone acetate ointment 

  • NDC Code(s): 59898-800-01, 59898-800-02, 59898-800-03, 59898-800-32, view more
    59898-800-36
  • Packager: Water-Jel Technologies
  • 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

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

  • Active ingredient

    Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

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  • Purpose

    Anti-itch cream

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  • Uses

    • for the temporary relief of itching associated with minor skin irritations and rashes
    • 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

    When using this product

    • avoid contact with eyes
    • do not begin use of any other hydrocortisone product unless you've consulted a doctor

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days
    • condition clears up and occurs again within a few days

    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; do not use, consult a doctor
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  • Other information

    • clean the affected area
    • store at room temperature
    • tamper evident sealed packets
    • do not use any opened or torn packets
    • you may report a serious adverse reaction to this product to 800-275-3433
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  • Inactive ingredients

    cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

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  • Questions ?

    800-275-3433

    info@waterjel.com

    www.waterjel.com

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  • Principal Display Panel

    image of pdpEnter section text here

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  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  
    anti-itch cream ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59898-800
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM  
    LIGHT MINERAL OIL  
    STEARIC ACID  
    GLYCERYL MONOSTEARATE  
    POLYETHYLENE GLYCOLS  
    CETYL ALCOHOL  
    TROLAMINE  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    DIAZOLIDINYL UREA  
    PROPYLPARABEN  
    GLYCERIN  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59898-800-03 25 in 1 BOX, UNIT-DOSE
    1 0.9 g in 1 PACKET
    2 NDC:59898-800-02 144 in 1 BOX, UNIT-DOSE
    2 0.9 g in 1 PACKET
    3 NDC:59898-800-01 1728 in 1 CARTON
    3 0.9 g in 1 PACKET
    4 NDC:59898-800-36 0.9 g in 1 PACKET
    5 NDC:59898-800-32 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 04/30/2010
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(59898-800)
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