Label: BAC-D HAND AND WOUND SANITIZER- benzalkonium chloride 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 January 3, 2022

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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.

    When using this product 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:

    • Apply on hands as needed. Rub briskly together until dry. • Apply on wounds 3 times a day after cleaning. Wipe excess with sterile gauze. May be bandaged once dry.

  • Inactive ingredients

    ionized water, carbamide

  • SPL UNCLASSIFIED SECTION

    DUAL PURPOSE

    EXTENDED PROTECTION*

    Eliminates 99.99% of Germs

    alcohol-free  •  triclosan-free  •  fragrance-free

    Non-Irritating / Non-Stinging

    Antimicrobial & Antiseptic

    Tough on Germs

    Gentle on skin

    BAC-D Antibacterial Hand Sanitizer and Wound Care kills bacteria and many common viruses without irritating the skin. It continues to reduce contamination even after dry and gently promotes wound healing. It will not sting, dry, irritate or damage healthy tissue, and is safe to use on cuts, scrapes, burns, lacerations and skin infections.

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

    MADE IN THE U.S.A.

    Manufactured by

    AEC Consumer Products

    135 Airport Road

    Fayetteville, NC 28306

    Learn more at BAC-D.com

    1-888-232-3344

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BAC-D  HAND AND WOUND SANITIZER
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86089-600
    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:86089-600-013785 mL in 1 JUG; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2017
    Labeler - AEC Consumer Products, LLC (080994102)
    Establishment
    NameAddressID/FEIBusiness Operations
    AEC Consumer Products, LLC080994102manufacture(86089-600) , pack(86089-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holly Oak Chemical, Inc.057840035manufacture(86089-600) , pack(86089-600)
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