Label: HYDROCORTISONE- anti-itch cream ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 19, 2024

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  • Active ingredient

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations and rashes
    • other uses should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

    Do not use

    Do not use ▪ in or near eyes

    ▪ for a 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

    • Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days

      ▪ symptoms clear up and occur again within a few days

    Keep out of the reach of children

    If swallowed get medical help or contact poison control (800-222-1222) 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

    • store at room temperature
  • Inactive ingredients

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

  • Questions ?

    1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Carton Image

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    anti-itch cream ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5632(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 10000 (UNII: H57W405143)  
    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:0924-5632-0320 in 1 CARTON12/20/2019
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5632-0425 in 1 CARTON12/20/2019
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5632-0110 in 1 CARTON12/20/2019
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5632-000.9 g in 1 PACKET; Type 0: Not a Combination Product12/20/2019
    5NDC:0924-5632-0212 in 1 CARTON12/20/2019
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5632-0560 in 1 CARTON12/20/2019
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0924-5632-06144 in 1 CARTON12/20/2019
    70.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/20/2019
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5632) , repack(0924-5632)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5632) , repack(0924-5632)
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