ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]

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ITCH RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]
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NDC 61010-8300-1
Set ID 4f4c801b-d894-4fa3-b024-6ca41a5f2a95
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
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 products using 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:

    • 12 and over: apply to affected area not more than 3 to 4 times daily
    • under 12: consult a doctor
  • Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    NDC 61010-8300-1

    Safetec

    Diphenhydramine

    Itch Relief Spray

    Relief from pain and

    itching due to insect

    bites and rashes from

    poison ivy, poison oak

    and poison sumac.

    Manufactured by

    SAFETEC OF AMERICA, Inc.

    Buffalo, NY 14215 800-456-7077

    www.safetec.com

    2 fl. oz. (59.1ml) Reorder no. 57001

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8300
    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:61010-8300-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/02/2013
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-8300)
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