KAY ALCOHOL FOAM HAND SANITIZER - alcohol solution 
Kay Chemical Company

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.

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Drug Facts

Active ingredient

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

Purpose

Antiseptic handwash

Uses

Warnings

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

Other information

Inactive ingredients  water (aqua), PEG-10 dimethicone, ethylhexylglycerin, farnesol, bisabolol, tert-butyl alcohol, denatonium benzoate

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

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)

Revised: 11/2022
Document Id: fd06b1a0-32f2-4d23-8e4c-f5b197d8c7ac
Set id: 435085a5-2e67-4dfa-999c-081911abf05f
Version: 2
Effective Time: 20221114
 
Kay Chemical Company