Label: ANTISEPTIC- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 27, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Uses

    • Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water
  • Warnings

    For external use only

    Do not use in the eyes. If this happens, rinse thoroughly with water.

    Stop use and ask doctor if irritation or redness develop and persists for more than 72 hours

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.
  • Inactive ingredients

    Purified water, alcohol

  • PRINCIPAL DISPLAY PANEL – packet label

    Well at
    Walgreens

    NDC 0363-7110-00

    Antiseptic
    Towelette

    Benzalkonium Chloride/
    First Aid Antiseptic

    1 SINGLE-USE
    PREMOISTENED TOWELETTE

    PRINCIPAL DISPLAY PANEL – packet label
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.2478 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7110-000.0025 L in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/27/2013
    Labeler - Walgreen Co. (008965063)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0363-7110)
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