Label: ANTIBACTERIAL- 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 June 3, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride - 0.13%......................Purpose - Antibacterial

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Uses for handwashing or decrease bacteria to the skin

  • WARNINGS

    For external use only

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • WHEN USING

    When using the product

    • do not get into eyes. If contact occurs, rinse eye thoroughly with water
  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet Hands
    • Apply palmful to hands
    • Scrub thoroughly
    • Rinse
  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl14700)

  • PRINCIPAL DISPLAY PANEL

    32

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71020-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71020-100-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/03/2020
    2NDC:71020-100-641900 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    Labeler - Sante Manufacturing Inc (242048747)
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