Label: HYDROCORTISONE 1% cream

  • NDC Code(s): 58228-2045-1, 58228-2045-2
  • Packager: ProStat First Aid LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2023

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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 Exteranl Use Only

    If pregnant or breast-feeding

    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 within 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

    PS-2045-BX-MASTERHydrocortisone Cream USP 1%

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 1% 
    hydrocortisone 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2045
    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
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-2045-21800 in 1 CASE04/10/2023
    1NDC:58228-2045-125 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 not finalpart34804/10/2023
    Labeler - ProStat First Aid LLC (061263699)
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