Label: HYDROCORTISONE- anti-itch cream ointment

  • 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 December 19, 2019

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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 not finalpart34812/20/2019
    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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