Label: ANTISEPTIC- alcohol, benzocaine 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 12, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ethyl alcohol 50.0%

    Benzocaine 6.0%

  • Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

  • Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    Do not use

    • over large areas of the body
    • in eyes
    • over raw or blistered areas

    Stop use and ask doctor if conditions worsen or persist for 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

    Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

  • Inactive ingredients

    benzalkonium chloride, menthol, purified water

  • PRINCIPAL DISPLAY PANEL – pouch label

    NDC 61010-7200-0

    Safetec

    Sting Relief
    Insect Bite
    Antiseptic and Pain Reliever

    Contents: 1 single-use, premoistened towelette

    Manufactured by SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215 800-456-7077 www.safetec.com

    EXP. LOT

    PRINCIPAL DISPLAY PANEL – pouch label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    alcohol, benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-7200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol500 mg  in 1 g
    benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    menthol (UNII: L7T10EIP3A)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-7200-00.8 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/12/2011
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE
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