Label: HYDROCORTISONE cream

  • NDC Code(s): 47682-211-12, 47682-211-35, 47682-211-73, 47682-211-99
  • 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, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
    • 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
    • with anyother Hydrocortisone product unless you have consulted adoctor
    • if you have vaginal discharge, consulkt a doctor

    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.

    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
  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive ingredients

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

  • QUESTIONS

    Questions or Comments? 1-800-634-7680

  • Medi-First Hydrocortisone Label

    MEDI-FIRST®

    1% Hydrocortisone Cream

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

    Product # 24369

    10 units of 0.9gm (1/32oz) Packets

    24369

  • PRINCIPAL DISPLAY PANEL

    Medi First® Plus

    Hydrocortisone Cream 1%

    Temporary releif of itching associated with minor skin irritation, inflamation and rashes

    25 units / Net Wt 0.9 g (1/32 oz)

    Item #93373

    93373 Hydro

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-211
    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:47682-211-7325 in 1 BOX04/15/2013
    1NDC:47682-211-990.9 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:47682-211-1210 in 1 BOX04/15/2013
    2NDC:47682-211-990.9 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:47682-211-35144 in 1 BOX04/15/2013
    3NDC:47682-211-990.9 g in 1 POUCH; 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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