Label: CAREALL HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

  • NDC Code(s): 51824-098-09, 51824-098-14, 51824-098-25
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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 right away

  • Uses

    • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:   eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap
    • 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.  Consult a doctor

    When using this product:

    Avoid contact with the eyes

    Do not begin use of any other hydrocortisone product unless you have consulted a doctor

    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

  • 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 do not use.  Ask a doctor.

  • INACTIVE INGREDIENT

    Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Hydrocortisone Packet Box Label

  • INGREDIENTS AND APPEARANCE
    CAREALL HYDROCORTISONE   MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-098
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    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:51824-098-14144 in 1 BOX01/01/2024
    1NDC:51824-098-09.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:51824-098-2525 in 1 BOX01/01/2024
    2NDC:51824-098-09.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2024
    Labeler - New World Imports, Inc (075372276)
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