Label: KAY CHEMICAL HAND SANITIZER FOAM- ethyl alcohol 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 28, 2022

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  • Active Ingredient

    Ethyl alcohol 54.7 w/w (equivalent to 62.5% v/v)

  • Purpose

    Antiseptic Handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame, heat, sparks and sources of static discharge.
    • Contents under pressure. Do not store at temperatures above 120°F (48°C), puncture or incinerate
    • Operate only with spout pointing down

    Do not use

    • In eyes

    When using this product

    • If in eyes, rinse promptly and thoroughly with water
    • Discontinue use if irritation and redness develop

    Stop use and ask a doctor if skin irritation or redness develop occurs 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

    • Spread thoroughly onto hands and rub until dry
  • Other Information

    • for additional information, see Safety Data Sheet (SDS)
    • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

    Inactive Ingredients water (aqua), isobutane, glycerin, cetearyl alcohol, hydrofluorocarbon 152A, propane, polysorbate-60, sodium lauroyl lactylate, steareth-20, sodium benzoate, tert-butyl alcohol, denatonium benzoate

  • QUESTIONS

    Questions? Call 1-800-529-5458

  • Representative Label and Principal Display Panel

    KAY®

    Hand Sanitizer Foam

    Net Contents: 425 g (15 oz)

    Active Ingredient: 54.7% w/w (equivalent to 62.5% v/v)

    1110978

    ECOLAB

    This product may be patented | Este producto

    puede ser patentado: www.ecolab.com/patents

    Distributed by | Distribuido por:

    Kay Chemical Company · 8300 Capital Drive

    Greensboro, NC 27409-9790 USA

    Customer Service: (800) 529-5458

    ©2022 Kay Chemical Company

    All rights reserved | Todas los derechos reservados

    Made in USA | Hecho en Estados Unidos

    822113 • KUSA 775938/8001/1122

    Representative Label

  • INGREDIENTS AND APPEARANCE
    KAY CHEMICAL HAND SANITIZER FOAM 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL54.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    isobutane (UNII: BXR49TP611)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPANE (UNII: T75W9911L6)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-309-13425 g in 1 CAN; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - Kay Chemical (003237021)
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