Label: CHEMSTAR FOAMING HAND SANITIZER- 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 November 14, 2022

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  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic handwash

  • INDICATIONS & USAGE

    • for handwashing to decrease bacteria on skin
  • Warnings

    For external use only

    Do not use

    • in eyes

    When using this product

    • if in eyes, rinse promptly and throughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask doctor if 

    • skin irritation or redness persists for more than 72 hours

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

  • Directions

    • wash hands to remove soil
    • dispense palmful
    • spread to cover hands, rub in well
    • air dry, do not rinse or towel dry
  • Other Information

    • For additional information, see Safety Data Sheet (SDS)
    • For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, CI 16035 (FD&C Red 40), CI 42090 (FD&C Blue 1)

  • QUESTIONS

    Questions? call 1-800-529-5458

  • Principal Display Panel and Representative label

    CHEMSTAR

    Foaming

    Hand Sanitizer

    Sanitizante de manos en espuma

    KEEP OUT OF REACH OF CHILDREN

    FOR INSTITUTIONAL USE ONLY

    Benzalkonium chloride 0.1%

    Net Contents: 42 US fl oz (1250 ml)

    1111302

    Distributed by:

    Kay Chemical Company

    8300 Capital Drive • Greensboro, NC 27409

    Made in USA • CSUSA 778273/8000/0621

    representative label

  • INGREDIENTS AND APPEARANCE
    CHEMSTAR FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-316-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/08/2010
    Labeler - Kay Chemical Company (003237021)
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