Label: CLEANSING AND 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 October 28, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Cleansing and Antibacterial

  • Active Ingredient(s)

    Benzalkonium chloride 0.24mg/mL. Purpose: Antiseptic

  • Purpose

    Antiseptic, Cleansing and Antibacterial

  • Use

    Cleansing and Antibacterial to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Press and spray evenly at 20cm way from hangds, skin or clothes; you may increase dosage as appropriate.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    forsythia suspensa fruit, lonicera japonica flower, purified water USP

  • Package Label - Principal Display Panel

    01

  • INGREDIENTS AND APPEARANCE
    CLEANSING AND ANTIBACTERIAL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80945-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80945-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2020
    Labeler - Yiling Health Science & Technology Co. Ltd. (544332306)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nox Bellcow Cosmetics Co., Ltd.528103343manufacture(80945-101)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!