Label: HYDROCORTISONE- anti-itch cream 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

Drug Label Information

Updated February 13, 2024

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  • Active ingredient

    Hydrocortisone acetate (equivalent to  Hydrocortisone 1%)

  • Purpose

    Anti-itch cream

  • 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
  • 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.

  • 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
  • Other information

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

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

  • Questions ?

    800-275-3433

    info@waterjel.com

    www.waterjel.com

  • Principal Display Panel

    HYUD

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    anti-itch cream ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-800-0325 in 1 BOX, UNIT-DOSE04/30/2010
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59898-800-02144 in 1 BOX, UNIT-DOSE04/30/2010
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-800-011728 in 1 CARTON04/30/2010
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:59898-800-360.9 g in 1 PACKET; Type 0: Not a Combination Product04/30/2010
    5NDC:59898-800-3228 g in 1 TUBE; Type 0: Not a Combination Product04/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/30/2010
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-800)
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