Label: KAY ALCOHOL FOAM HAND SANITIZER- 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 14, 2022

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  • Active ingredient

    Ethyl alcohol, 62% w/w (equivalent to 70% v/v)

  • Purpose

    Antiseptic handwash

  • Uses

    • for hand washing 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.

    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 and redness persists from 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
    • spread to cover hands thoroughly, rub to 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), PEG-10 dimethicone, ethylhexylglycerin, farnesol, bisabolol, tert-butyl alcohol, denatonium benzoate

  • QUESTIONS

    Questions? call 1-800-529-5458

  • Principal display panel and representative label

    NDC 63146-313-09   KAY

    Alcohol Foam

    Hand Sanitizer

    Active ingredient: Ethyl alcohol 62% w/w (equivalent to 70% v/v)

    Net contents: 40.6 US fl oz (1200 mL)

    SDS-NC-872, SDS-WI-15014, SDS-NJ-20007

    Distributed by

    Kay Chemical Company

    8300 Capital Drive - Greensboro NC 27409-9790 USA

    Customer Service: (800) 529-5458

    (c)2020 Kay Chemical Company

    All rights reserved

    Made in USA

    representative label

  • INGREDIENTS AND APPEARANCE
    KAY ALCOHOL FOAM HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FARNESOL (UNII: EB41QIU6JL)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-313-091200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/02/2020
    Labeler - Kay Chemical Company (003237021)
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