Label: KAY ALCOHOL FOAM HAND SANITIZER- alcohol solution
- NDC Code(s): 63146-313-09
- Packager: Kay Chemical Company
- 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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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
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INGREDIENTS AND APPEARANCE
KAY ALCOHOL FOAM HAND SANITIZER
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:63146-313-09 1200 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/02/2020 Labeler - Kay Chemical Company (003237021)