drug facts

drug facts
SPL v1
SPL
SPL Set ID 37429e8a-581d-443e-8e8a-71fbb53c7c56
Route
topical
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
water bis-peg-12 dimethicone (500 mpa.s) ethylhexylglycerin farnesol .alpha.-bisabolol, (+/-)- tert-butyl alcohol denatonium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-31

Purpose

Antiseptic handwash

Description

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


Medication Information

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge.
Uses
  • for hand washing to decrease bacteria on the skin

Purpose

Antiseptic handwash

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
Description

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

Section 50565-1

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

Section 50569-3

Stop use and ask doctor if skin irritation and redness persists from more than 72 hours

Section 51727-6

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

Section 53413-1

Questions? call 1-800-529-5458

Do Not Use
  • in eyes

Active Ingredient

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

When Using This Product
  • if in eyes, rinse promptly and throughly with water
  • discontinue use if irritation and redness develop

Principal Display Panel and Representative Label

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


Structured Label Content

Warnings
  • For external use only
  • FLAMMABLE, keep away from fire or flame, heat, sparks and sources of static discharge.
Uses
  • for hand washing to decrease bacteria on the skin

Purpose

Antiseptic handwash

Directions
  • wash hands to remove soil
  • spread to cover hands thoroughly, rub to dry

Other Information (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
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 50569-3 (50569-3)

Stop use and ask doctor if skin irritation and redness persists from more than 72 hours

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions? call 1-800-529-5458

Do Not Use (Do not use)
  • in eyes

Active Ingredient (Active ingredient)

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

When Using This Product (When using this product)
  • if in eyes, rinse promptly and throughly with water
  • discontinue use if irritation and redness develop

Principal Display Panel and Representative Label (Principal display panel and representative label)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)