Label: FOAMING HAND SANITIZER REFILL FRAGRANCE FREE- 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 February 8, 2021

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antimicrobial

  • Uses

    • hand sanitizer that helps decrease bacteria on the skin
    • recommend for repeated use

  • Warnings

    For external use only, do not use in ears, mouth, or eyes.

    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.

    Keep out of reach of children

    Children should be supervised when using this product.

  • Directions

    • pour liquid into a foaming dispenser
    • pump a small amount of foam into palm of hand
    • spread thoroughly on both hands
    • rub hands together until dry

  • Inactive Ingredients

    Citric Acid, Dimonium Chloride Cocoamidopropyl Hydroxysultaine, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Rose Ether, Water.

  • Package Labeling: 473ml

    Bottle

  • Package Labeling: 946ml

    Bottle2

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER REFILL FRAGRANCE FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81527-000
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81527-000-16473 mL in 1 CARTON; Type 0: Not a Combination Product02/01/2021
    2NDC:81527-000-32946 mL in 1 CARTON; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2021
    Labeler - Bocks Inc (082200343)
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!