Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 901abea4-b82e-43c7-a1ac-0cdc1555dbc2
Route
TOPICAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (60 mL)
Inactive Ingredients
Water Isopropyl Alcohol Trolamine Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Propylene Glycol Myristyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Ethanol 60% by volume

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Ethanol 60% by volume

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

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

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.
Directions
  • Apply a liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to area around nails and between fingers
Do Not Use
  • In eyes
  • on deep cuts or puncture wounds
Active Ingredient

Ethanol 60% by volume

Other Information
  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHING WITH SOAP AND WATER
  • 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 Ingredients

​water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

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
  • Eye or skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

KAY

QSR

Hand Sanitizer

FOR INSTITUTIONAL USE ONLY

Ethanol 60% by volume

Net contents: 40.6 US fl oz (1200 mL)

Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Food Code.

(2017 Food Code).

SDS-NC-872, SDS-NJ-20007

Distributed by

Kay Chemical Company

8300 Capital Drive · Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458

©2020 Kay Chemical Company

All rights reserved | KUSA 756614/8004/1020


Structured Label Content

Uses
  • For handwashing to decrease bacteria on 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 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.
Directions
  • Apply a liberal amount into hand
  • Spread by rubbing hands together
  • Rub to dryness with attention to area around nails and between fingers
Do Not Use (Do not use)
  • In eyes
  • on deep cuts or puncture wounds
Active Ingredient (Active ingredient)

Ethanol 60% by volume

Other Information (Other information)
  • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHING WITH SOAP AND WATER
  • 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 Ingredients (Inactive ingredients)

​water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

When Using This Product (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 (Stop use and ask a doctor if)
  • Eye or skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

KAY

QSR

Hand Sanitizer

FOR INSTITUTIONAL USE ONLY

Ethanol 60% by volume

Net contents: 40.6 US fl oz (1200 mL)

Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Food Code.

(2017 Food Code).

SDS-NC-872, SDS-NJ-20007

Distributed by

Kay Chemical Company

8300 Capital Drive · Greensboro, NC 27409-9790 USA Customer Service: (800) 529-5458

©2020 Kay Chemical Company

All rights reserved | KUSA 756614/8004/1020


Advanced Ingredient Data


Raw Label Data

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