Label: HYDROCORTISONE CREAM 1% cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 19, 2024

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  • Active Ingredient

    Hydrocortisone USP 1%

  • Purpose

    Antipruritic (Anti-Itch)

  • Use(s)

    For the Temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching

  • Warnings

    For External Use Only

    If pregnant or breastfeeding

    Ask a health professional before use

    Do not use

    • In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again with a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days)

    • Bleeding occurs due to anal itching

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 of age: Consult a doctor

    • When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying.

    • Children under 12: Consult a doctor before using for anal itching.

  • Other Information

    • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper Evident. Do not use if packet is torn, cut or opened.

  • Inactive Ingredients

    Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolatum

  • Questions?

    1-888-900-2920 Monday - Friday, 8AM - 4PM PST

  • Label

    FL-2045_BX_MASTERFL-2045

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM 1% 
    hydrocortisone cream 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-6245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-6245-11800 in 1 CASE01/26/2024
    125 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/26/2024
    Labeler - Front Line Safety (061263699)
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