Label: ARTEMIS ALCOHOL-FREE ANTISEPTIC FOAM HAND- benzalkonium chloride soap

  • 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 December 19, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • Uses

    • For washing hands to decrease bacteria on the skin.
    • Recommended for repeated use.
  • WARNINGS

    Warnings

    • For external use only.

    • Do not use in eyes. If contact occurs, flush eyes with water.

    • Stop use and ask a doctor if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • Pump a small amount of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands for 15 seconds.
    • Rinse with potable water.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, dihydroxypropyl PEG-5 linoleammonium chloride, glycereth-2cocoate, behentrimonium chloride, dihydroxyethyl cocamine oxide, fragrance

  • SPL UNCLASSIFIED SECTION

    ARTEMIS BIOSOLUTIONS

    Manufactured by Artemis BioSolutions.

    960 N. Industrial Dr., Ste.4 Elmhurst, IL 60126.

    Made in USA.

  • PRINCIPAL DISPLAY PANEL

    TRICLOSAN FREE


    ARTEMIS
    Many threats. One solution

    ANTISEPTIC FOAM HAND SOAP

    MOISTURIZES
    LEAVES SKIN SOFT

    Eliminates 99.999%
    OF MOST COMMON GERMS THAT MAY CAUSE ILLNESS


    Environmentally  Friendly
    8.4  floz (250ml)

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    ARTEMIS ALCOHOL-FREE ANTISEPTIC FOAM HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49765-410
    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
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49765-410-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/24/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/24/2011
    Labeler - Artemis Bio-Solutions Inc (116934417)
    Establishment
    NameAddressID/FEIBusiness Operations
    Artemis Bio-Solutions Inc116934417manufacture(49765-410)
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!