Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f82eaaaf-cead-497a-8b95-966831051187
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (54.7 g)
Inactive Ingredients
Water Isobutane Glycerin 1,1-difluoroethane Cetostearyl Alcohol Polysorbate 60 Propane Sodium Lauroyl Lactylate Steareth-20 Sodium Benzoate Tert-butyl Alcohol Denatonium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

Description

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

Purpose

Antiseptic Handwash


Medication Information

Purpose

Antiseptic Handwash

Description

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

Uses
  • For handwashing to decrease bacteria on the skin
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if skin irritation or redness develop occurs for more than 72 hours

Section 51727-6

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

Section 53413-1

Questions? Call 1-800-529-5458

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

Directions
  • Spread thoroughly onto hands and rub until dry
Do Not Use
  • In eyes
Active Ingredient

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

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
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


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation or redness develop occurs for more than 72 hours

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions? Call 1-800-529-5458

Purpose

Antiseptic Handwash

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

Directions
  • Spread thoroughly onto hands and rub until dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient

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

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
When Using This Product (When using this product)
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)