BAC-D HAND AND WOUND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [GREAT AMERICAN EMU COMPANY, LLC]

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BAC-D HAND AND WOUND SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [GREAT AMERICAN EMU COMPANY, LLC]
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NDC 86089-400-18
Set ID 51347d59-c0eb-4695-ba6e-46042f62110a
Category HUMAN OTC DRUG LABEL
Packager AEC CONSUMER PRODUCTS
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial and First aid antiseptic

  • Uses:

    •For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use. •For wound sanitizing to help prevent bacterial contamination in cuts, scrapes, burns, lacerations and skin infections.

  • Warnings:

    For external use only. Avoid contact with eyes. In case of eye contact, flush eyes with water. Discontinue use if irritation or redness develops. If condition persists for more than 72 hours consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions:

    •Spray hands as needed. •Spray wounds 3 times a day after cleaning.

  • Inactive ingredients:

    ionized water, carbamide

  • SPL UNCLASSIFIED SECTION

    DUAL PURPOSE

    EXTENDED PROTECTION*

    Eliminates 99.99% of Germs

    alcohol-free   |    triclosan-free

    Non-Irritating • Non-Stinging

    Antibacterial & Antiseptic

    MADE IN THE U.S.A.

    Manufactured for

    AEC Consumer Products

    4525 Campground Road

    Fayetteville, NC 28314

    www.BAC-D.com

    910-987-7964

    *Studies show Benzalkonium Chloride protects against infection for more than three hours.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BAC-D  HAND AND WOUND SANITIZER
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86089-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86089-400-1818 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201404/01/2020
    2NDC:86089-400-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2014
    Labeler - AEC CONSUMER PRODUCTS (080994102)
    Establishment
    NameAddressID/FEIBusiness Operations
    AEC CONSUMER PRODUCTS080994102manufacture(86089-400) , pack(86089-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holly Oak Chemical, Inc.057840035manufacture(86089-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141pack(86089-400)
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