Label: ITCH RELIEF- diphenhydramine hydrochloride liquid

  • 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 May 13, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Diphenhydramine hydrochloride 2%

  • Purpose

    External Analgesic

  • Uses:

    For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac.

  • Warnings

    For external use only

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine hydrochloride, even one taken by mouth

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • avoid contact with the eyes

    Stop use and ask doctor if

    • condition worsens
    • symptoms persist 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.

  • Directions:

    • do not use more than directed
    • adults & children12 and over: apply to affected area not more than 3 to 4 times daily
    • children under 12 years: consult a doctor
  • Inactive Ingredients

    germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Extra Strength

    Itch Relief

    Diphenhydramine HCl 2%

    Quick itch and pain relief.
    Use as a first aid
    treatment for insect bites
    and rashes from poison
    ivy, oak & sumac.
    Convenient pump spray
    allows no-touch
    application.

    2 fl. oz. (59.1ml)

    Xpect First Aid

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-8300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride20.3 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    edetate disodium (UNII: 7FLD91C86K)  
    glycerin (UNII: PDC6A3C0OX)  
    C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68421-8300-00.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/13/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/13/2013
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(68421-8300)
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