Label: SCOTT ANTIMICROBIAL FOAM- benzalkonium chloride solution

  • 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 16, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1% w/w

  • Purpose

    Antiseptic cleanser

  • Use

    For personal hand hygiene to help prevent the spread of certain bacteria.

  • Warnings

    • For External Use Only. Do not ingest. If swallowed, get medical help or contact a Poison Control Center immediately.
    • Use with caution in children.
    • Avoid contact with eyes. In contact occurs, flush eyes with water.
    • Discontinue use & consult a health care practitioner if irritation develops.

    • Keep out of reach of children.

    • Do not use if you are allergic to any ingredients.
  • Directions

    Apply small amount and lather in hands for at least 30 seconds.

    Adults: Supervise children when using this product. Do not dilute product. For occasional use as needed.

  • Other Information

    • Report serious side effects from this product to 1-877-561-6587
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice Powder, Citric Acid, Coco-Betaine, Glycerin, Panthenol, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Tocopheryl Acetate, Water/Eau.

  • Questions?

    1-888-346-4652

  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by Kimberly-Clark Global Sales, LLC,
    Roswell, GA 30076-2199

  • PRINCIPAL DISPLAY PANEL - 33.8 fl oz Bottle Label

    Scott®
    Brand

    Antimicrobial Foam Soap

    Benzalkonium
    Chloride Solution, NF

    For Domestic / Personal Care Use

    Kills 99.9% of most common germs†

    1 Liter
    (33.8 fl oz)

    DIN: 02458675

    †Enterococcus faecalis VRE; MDR,
    Enterococcus faecium, Pseudomonas aeruginosa,
    Escherichia coli, Staphylococcus epidermidis,
    Salmonella typhi, Streptococcus pyogenus,
    Listeria monocytogenes, Proteus vulgaris,
    Salmonella enterica

    20-29-382-0-01

    PRINCIPAL DISPLAY PANEL - 33.8 fl oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    SCOTT ANTIMICROBIAL FOAM 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Coco-Betaine (UNII: 03DH2IZ3FY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Aloe (UNII: V5VD430YW9)  
    Panthenol (UNII: WV9CM0O67Z)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-235-633 in 1 CARTON12/01/2016
    1NDC:55118-235-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E12/01/2016
    Labeler - Kimberly-Clark (830997032)
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!