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: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 15, 2019

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

  • 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
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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
    OTC monograph not finalpart34810/15/2019
    Labeler - Honeywell Safety Products USA, inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Safety Products USA, Inc079287321manufacture(0498-0801)