Label: CAREALL HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

  • NDC Code(s): 51824-050-01, 51824-050-09, 51824-050-14
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • Keep out of reach of Children

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

  • Uses

    Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal 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

    In the genital if you have a vaginal discharge.  Consult a doctor

    When using this product:

    Avoid contact with the eyes

    Do not use more than directed unless told to do so by a doctor.

    Do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if:

    Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor.

    Rectal bleeding occurs

  • Directions

    for itching of skin irritation, inflammation and rashes:

    • Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age do not use.  Ask a doctor.

    For external anal and genital itching, adults:

    • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.  
    • Gently dry by patting or blotting with toliet tissue or a soft cloth before applying.
    • apply to affected area not more than 3 to 4 times daily.
    • children under 12 years of age with external anal itching: ask a doctor.
  • INACTIVE INGREDIENT

    Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL

    HYD Image

  • INGREDIENTS AND APPEARANCE
    CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone Acetate1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    Chlorocresol (UNII: 36W53O7109)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (White Cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-050-0128 g in 1 TUBE; Type 0: Not a Combination Product04/27/2016
    2NDC:51824-050-14144 in 1 CONTAINER05/01/2022
    2NDC:51824-050-09.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/11/2016
    Labeler - New World Imports, Inc (075372276)