Label: HYDROCORTISONE - hydrocortisone acetate ointment

  • NDC Code(s): 0498-0800-01, 0498-0800-02, 0498-0800-03, 0498-0800-32, view more
    0498-0800-33, 0498-0800-34, 0498-0800-35
  • Packager: North Safety Products
  • 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

    (In each gram)

    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

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  • Warnings

    For external use only

    When using the product

    • avoid contact with eyes
    • do not begin use of any other hydrocortisone product unless you have consulted a doctor
    • do not use for the treatment of diaper rash

    Stop use and ask a doctor if

    • the condition gets worse
    • condition persists for more than 7 days
    • condition clears up and recurs within a few days

    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 and older:
    • clean the affected area
    • apply to the area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
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  • Other information

    • store at room temperature
    • tamper evident sealed packets
    • do not use any opened or torn packets
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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

    1-800-430-4110

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    anti-itch cream ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0498-0800
    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  
    CITRIC ACID MONOHYDRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-0800-03 25 in 1 BOX, UNIT-DOSE
    1 0.9 g in 1 PACKET
    2 NDC:0498-0800-02 144 in 1 BOX, UNIT-DOSE
    2 0.9 g in 1 PACKET
    3 NDC:0498-0800-01 1728 in 1 CARTON
    3 0.9 g in 1 PACKET
    4 NDC:0498-0800-32 20 in 1 BOX, UNIT-DOSE
    4 0.9 g in 1 PACKET
    5 NDC:0498-0800-33 100 in 1 BOX, UNIT-DOSE
    5 0.9 g in 1 PACKET
    6 NDC:0498-0800-34 10 in 1 BOX, UNIT-DOSE
    6 0.9 g in 1 PACKET
    7 NDC:0498-0800-35 0.9 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/06/2013
    Labeler - North Safety Products (019777263)
    Establishment
    Name Address ID/FEI Business Operations
    North Safety Products 019777263 manufacture(0498-0800)
    Establishment
    Name Address ID/FEI Business Operations
    Water-Jel Technologies 155522589 manufacture(0498-0800)
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