ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]

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ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CINTAS FIRST AID & SAFETY]
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NDC 68421-8300-0
Set ID fdcec01b-e4fe-4440-b6e1-572a13c49661
Category HUMAN OTC DRUG LABEL
Packager Cintas First Aid & Safety
Generic Name
Product Class
Product Number
Application Number PART348
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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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