Label: HYDROCORTISONE- anti-itch cream

  • NDC Code(s): 0498-0801-01, 0498-0801-02, 0498-0801-03, 0498-0801-32, view more
    0498-0801-33, 0498-0801-34, 0498-0801-35
  • Packager: Honeywell Safety Products USA, inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 22, 2024

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  • Active ingredient

    (In each gram)

    Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

  • Purpose

    Anti-itch cream

  • Uses

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

  • Warnings

    For external use only

    Ask a doctor before use if

    Ask a doctor before use if you are using any other hydrocortisone product

    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

    • condition worsens
    • 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.

  • 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
  • Other information

    • store at room temperature (do not freeze)
  • 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

  • Questions or comments?

    1-800-430-5490

  • Principal Display Panel

    hydrocortisone

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    anti-itch cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0801
    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
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0801-0325 in 1 BOX, UNIT-DOSE10/15/2019
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0498-0801-02144 in 1 BOX, UNIT-DOSE10/15/2019
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0498-0801-011728 in 1 CARTON10/15/2019
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0498-0801-3220 in 1 BOX, UNIT-DOSE10/15/2019
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0498-0801-33100 in 1 BOX, UNIT-DOSE10/15/2019
    50.9 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0498-0801-3410 in 1 BOX, UNIT-DOSE10/15/2019
    60.9 g in 1 PACKET; Type 0: Not a Combination Product
    7NDC:0498-0801-350.9 g in 1 PACKET; Type 0: Not a Combination Product10/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2019
    Labeler - Honeywell Safety Products USA, inc (118768815)
    Registrant - Honeywell Safety Products USA, Inc (118768815)
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