Label: MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone 1% spray

  • 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 June 18, 2018

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  • Active ingredient                                Purpose

    Hydrocortisone - 1.00%                       Anti-itch

  • PURPOSE

  • Uses

    Temporarily relieves itching associated with minor skin irritation and rashes due to:

    • eczema           • poison ivy, oak and sumac         • cosmetics

    • psoriasis         • soaps and detergents                  • jewelry

    • insect bites     • seborrheic dermatitis

  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    When using this product

    Avoid contact with the eyes. If condition worsens, or if symptoms
    persist for more than 7 days or clear up and occur again within a
    few days, stop use of this product and do not begin use of any
    other hydrocortisone product unless you have consulted a doctor.
    Do not use for the treatment of diaper rash. Consult a doctor.
    Do not puncture or incinerate. Contents under pressure. Do not
    store at temperatures above 120˚F.F

    Ask doctor before use if you are using any other hydrocortisone product

    Keep out of reach of the children

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

  • Directions

    • shake well
    • 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: ask a doctor

    • to apply to face, spray into palm of hand and gently apply

  • Inactive ingredients

    Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH ANTI-ITCH 
    hydrocortisone 1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-782
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Poloxamer 188 (UNII: LQA7B6G8JG)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-782-0385 g in 1 CAN; Type 0: Not a Combination Product04/07/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/07/2014
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(63868-782) , label(63868-782)
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