Label: BAK 1 750- 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 17, 2022

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  • PURPOSE

    Antiseptic

  • ACTIVE INGREDIENT

    Active Ingredient: Alkyl (50% C14, 40% C12, 10% C10) dimethyl benzyl ammonium chloride, 1.33 g/l.  Assayed by a non-USP method.

  • KEEP OUT OF REACH OF CHILDREN

    Warnings:  Keep out of reach of children.  Mixing this solution with soaps or detergents will destroy its germicidal properties.

  • INDICATIONS & USAGE

    Uses: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.

  • WARNINGS

    Caution:  Mixing this solution with soaps or detergents will destroy its germicidal properties.

  • DOSAGE & ADMINISTRATION

    Usage: Apply to affected area for first-aid treatment of minor cuts and abrasions.  Discontinue use and get medical aid if redness, irritation or infection develops.  In case of deep or puncture wounds consult a physician.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water

  • PRINCIPAL DISPLAY PANEL

    baklabel.jpg

    BAK Label

  • INGREDIENTS AND APPEARANCE
    BAK   1 750
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1713 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12745-145-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1954
    2NDC:12745-145-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1954
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/1954
    Labeler - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-145)
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