Label: RITE AID CORTISONE- hydrocortisone 1% spray

  • Category: HUMAN OTC DRUG LABEL

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 June 27, 2022

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  • ACTIVE INGREDIENT

    Hydrocortisone 1%

  • PURPOSE


    Anti-itch

  • INDICATIONS & USAGE

    For the temporary relief of itching associated with minor skin irritation and rashes due to eczema, poison ivy, oak, and sumac, cosmetics, jewelry, soaps and detergents, and insect bites. Other uses of this product should be only under the advice and supervision of a doctor.

  • WARNINGS

    For external use only. Flammable--Keep away from fire or flame. Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

  • INACTIVE INGREDIENT

    Alcohol Denat., Dimethyl Isosorbide, Glycerin, Water

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    RITE AID CORTISONE 
    hydrocortisone 1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0113
    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
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0113-385 g in 1 CAN; Type 0: Not a Combination Product03/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2021
    Labeler - Rite Aid (014578892)
    Registrant - Derma Care Research Labs, LLC (116817470)
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