Label: HYDROCORTISONE CREAM 1% WITH ALOE VERA- hydrocortisone cream

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

Drug Label Information

Updated January 11, 2024

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

  • Drug Facts

  • Active Ingredient

    Hydrocortisone USP 1%

  • Purpose

    Anti-itch

  • Uses

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

  • Warnings

    For external use only

    Do not use • for the treatment of diaper rash. Ask a doctor.  • for external genital itching if you have a vaginal discharge. Ask a doctor.  • for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

    When using this product • do not get into the eyes  • for external anal itching, do not use more than directed, unless told so by a doctor.  • do not put into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily.  • children under 2 years: ask a doctor  • For external anal itching in adults: • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with appropriate cleansing pad  • gently dry by patting or blotting with toilet tissue or soft cloth before applying  • for external anal itching in children under 12 years: ask a doctor

  • Other information

    • Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiration Date

  • Inactive ingredients

    Aloe Vera Leaf, Cetostearyl Alcohol, Glyceryl Stearate SE, Methylisothiazolinone, Propylene Glycol, Water, Stearic Acid, Trolamine, White Petrolatum

  • SPL UNCLASSIFIED SECTION

    Maximum Strength Anti-itch Cream

    Compared to the active ingredient in Cortizone 10®

    *Cortizone 10®*
    *This product is not affiliated with, manufactured by, or produced by the makers or owners of Cortisone 10

    Distributed by.

    EzriCare, LLC

    Lakewood, NJ

    www.EzriCare.com

    Made in India

  • Packaging

    Ezricare-202

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE CREAM 1% WITH ALOE VERA 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79503-202
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79503-202-301 in 1 CARTON06/01/202107/01/2025
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/202107/01/2025
    Labeler - Ezricare Llc (117573818)