DUKAL STING RELIEF PAD (BENZOCAINE) SWAB [DUKAL CORPORATION]

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DUKAL STING RELIEF PAD (BENZOCAINE) SWAB [DUKAL CORPORATION]
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NDC 65517-0005-1
Set ID 67c1ddc7-8fde-4431-84cb-f757682d5f3e
Category HUMAN OTC DRUG LABEL
Packager Dukal Corporation
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Benzocaine, 6% w/v

    Isopropyl Alcohol 60% w/v

  • Purpose

    Topical Anesthetic

    Antiseptic

  • INDICATIONS & USAGE

  • Directions

    Apply to affected area 3-4 times daily. For adults and children 2 years of age and older. Children under 2 years; consult physician.

  • WARNINGS

    Do Not Use

    • In the eyes. If contact occurs, rinse thoroughly with water

    Stop Use

    If irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

    Caution Flammable

    Keep out of reach of children.

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

  • Inactive Ingredient

    Purified Water

    D07110607 Rev5

  • Principal Display Panel - 0.4 mL Pouch Label

    DUKAL™
    CORPORATION

    REF
    856

    NDC 65517-0005-1
    STING RELIEF PAD

    For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

    For External Use Only

    1 Pouch

    DUKAL CORPORATION • (631) 656-3800
    Ronkonkoma, New York • www.dukal.com

    Made in China, Hecho en China, Fabriqué en Chine

    Principal Display Panel - 0.4 mL Pouch Label
  • INGREDIENTS AND APPEARANCE
    DUKAL STING RELIEF PAD 
    benzocaine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 60 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.6 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-0005-10.4 mL in 1 POUCH; Type 0: Not a Combination Product06/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2010
    Labeler - Dukal Corporation (791014871)
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