Label: THERACARE HYDROCORTISONE CREAM- hydrocortisone cream

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

Drug Label Information

Updated May 21, 2024

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

  • Active Ingredient:

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
      • eczema
      • psoriasis
      • poison ivy, oak, sumac
      • insect bites
      • detergents
      • jewelry
      • cosmetics
      • soaps
      • seborrheic dermatitis
      • temporarily relieves external anal and genital itching
      • other uses of this product should only be under the advice and supervision of a doctor
  • Warnings

    For external use only

    Do not use

    • in the genital area if you have a vaginal discharge.
    • for the treatment of diaper rash.
    • with any other hydrocortisone product unless you have asked a doctor

    When using this product

    • use only as directed
    • avoid contact with eyes
    • do not use more than directed unless told to do so by a doctor
    • do not put directly into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
    • rectal bleeding occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • for itching of skin irritation, inflammation, and rashes:
    • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a physician
    • for external anal and genital itching, adults and children 12 years of age and over:
      • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
      • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
      • apply to affected area not more than 3 to 4 times daily
      • children under 12 years of age: consult a physician
  • Other information

    Store at 20-25C (68-77F)

    do not use if tube seal under cap is broken

  • Inactive Ingredients


    ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl 1-stearate, mineral oil, phenoxyethanol, water, white petrolatum

  • TheraCare Hydrocortisone Cream

    labelPack

  • INGREDIENTS AND APPEARANCE
    THERACARE HYDROCORTISONE CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-220
    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)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-220-011 in 1 CARTON07/01/2023
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/01/2023
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71101-220)