Label: HYDROCORTISONE cream

  • NDC Code(s): 47682-397-12, 47682-397-35, 47682-397-71, 47682-397-73, view more
    47682-397-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrocortisone 1.0%

  • PURPOSE

    Purpose

    Anti itch

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
    • for external genital, feminine and anal itching
    • other uses of this product should be only under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

    Do not use

    • for the treatment of diaper rash
    • in eyes
    • for feminine itching

    Stop use and ask a doctor if

    • condition worsens or lasts more than 7 days, or clears and occurs again within a few days
    • you begin use of any other Hydrocortisone product unless you have consulted a doctor
    • bleeding occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
    • children under 12 years of age: for external anal itching, consult a doctor
    • children under 2 years of age: do not use, consult a doctor
    • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
    • gently dry by patting or botting with toilet tissue or a soft cloth before application of this product

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature (do not freeze)
    • tamper evident, do not use any opened or torn packets
  • QUESTIONS

    Questions or comments?

    1-800-869-6970

  • INACTIVE INGREDIENT

    Inactive ingredient

    emulsifying wax, ethanoll, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • PRINCIPAL DISPLAY PANEL

    Green Guard Hydrocortisone Label

    Maximum Strength

    Hydrocortisone
    cream 1%

    Temporary relief of itching associated with minor skin irritation, inflammation and rashes

    Green Guard

    Order # 3103

    25 Per Box

    Net Wt 0.9 g (1/32 oz) Packets

    3103

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-397
    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
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-397-7120 in 1 BOX04/15/201307/01/2019
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-397-1210 in 1 BOX04/15/201307/01/2019
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-397-7325 in 1 BOX06/06/2016
    3NDC:47682-397-990.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-397-35144 in 1 BAG06/30/2017
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/15/2013
    Labeler - Unifirst First Aid Corporation (832947092)
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