Label: BAC-D FOAMING ANTIBACTERIAL HAND 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 November 10, 2015

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  • Active ingredient 

    Benzalkonium chloride 0.13 %

  • Purpose

    Antimicrobial

  • Keep out of reach of children.

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

  • Uses

    • decrease bacteria and sanitizes skin 
    • recommended for repeated use
  • Warnings

    For external use only. 

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water .

    Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours

  • Directions

    • pump a small amount of foam in to palm of hand 
    • rub thoroughly over all surface of both hands
    • rub hands together briskly until dry.

  • Inactive ingredients 

    Ionized water, Carbamide

  • SPL UNCLASSIFIED SECTION

    Made in the U.S.A 

    Manufactured for 

    RDM Products Inc.

    PO Box 35003

    Fayetteville, NC 28303

    910-491-7371

    www.BAC-D.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BAC-D FOAMING ANTIBACTERIAL HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69082-600
    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:69082-600-1750 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/12/2014
    Labeler - RDM Products, Inc (034340230)
    Establishment
    NameAddressID/FEIBusiness Operations
    RDM Products, Inc034340230manufacture(69082-600)
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