Label: HYDROCORTISONE cream

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

Drug Label Information

Updated December 10, 2024

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  • Drug Facts

  • Active ingredient

    Hydrocortisone 1%

    Purpose

    Anti-itch

  • Uses

    • for the temporary relief of itching associated with minor irritations and rashes
    • other uses of this product should be only under the advice and superivision of a doctor.
  • Warnings

    For external use only.

    Do not use

    for the treatment of diaper rash. Consult a doctor.

    Stop use and ask a doctor if

    • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
    • you begin use of any other hydrocortisone product
    • bleeding occurs

    Keep out of reach of children.

    If swallowed 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 of age: do not use.
  • Inactive ingredients

    Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82942-1003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82942-1003-10.9 g in 1 PACKET; Type 0: Not a Combination Product05/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/08/2023
    Labeler - J&A Digital Inc. (040268672)
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