Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f572be64-6af9-4b4b-bd5b-cd031608de24
Route
TOPICAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (5 mg)
Inactive Ingredients
Water Potassium Cocoate Hexylene Glycol Sodium Sulfate Anhydrous Edetate Sodium Sodium Lauryl Sulfate Glycerin Sodium Citrate Glyceryl Oleate Sodium Glycolate Caprylyl/capryl Glucoside Lauryl Glucoside Methylchloroisothiazolinone Fd&c Yellow No. 5 Methylisothiazolinone Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-04

Description

Chloroxylenol, 0.5%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Chloroxylenol, 0.5%

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 51727-6

Inactive ingredients  water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, sodium citrate, glyceryl oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, lauryl glucoside, methylchloroisothiazolinone, yellow 5, methylisothiazolinone, red 4

Warnings
  • For external use only
Directions
  • Wet hands and forearms. • Apply palmful to hands and forearms. •  Scrub Thoroughly. •  Rinse and dry.
Do Not Use
  • In eyes
Questions?

Questions? Call 1-800-529-5458

Active Ingredient

Chloroxylenol, 0.5%

Other Information
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026 (number is in the US).
  • If located outside the United States and Canada, call collect 1 651 222 5352
When Using This Product
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Stop Use and Ask Doctor If

Skin irritation or redness occurs for more than 72 hours

Representative Label and Principal Display Panel

ECOLAB

Kay Foaming 

Antibacterial Handsoap

Active Ingredient: Chloroxylenol 0.5%

Instant foam lathers fast • Mild, pH-balanced formula

Fresh, clean fragrance

KAY® Foaming Antibacterial Handsoap is a rich lather hand soap

with a balanced blend of cleaning agents and skin protecting

moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Manufactured by: Ecolab Inc

1 Ecolab Place · St. Paul, MN 55102 USA

Customer Service: (800) 529-5458

©2025 Kay Chemical Company

All rights reserved | Made in USA

KUSA 785111/8000/0925


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 51727-6 (51727-6)

Inactive ingredients  water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, sodium citrate, glyceryl oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, lauryl glucoside, methylchloroisothiazolinone, yellow 5, methylisothiazolinone, red 4

Purpose

Antiseptic handwash

Warnings
  • For external use only
Directions
  • Wet hands and forearms. • Apply palmful to hands and forearms. •  Scrub Thoroughly. •  Rinse and dry.
Do Not Use (Do not use)
  • In eyes
Questions?

Questions? Call 1-800-529-5458

Active Ingredient (Active ingredient)

Chloroxylenol, 0.5%

Other Information
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026 (number is in the US).
  • If located outside the United States and Canada, call collect 1 651 222 5352
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 Doctor If (Stop use and ask doctor if)

Skin irritation or redness occurs for more than 72 hours

Representative Label and Principal Display Panel (Representative label and Principal Display Panel)

ECOLAB

Kay Foaming 

Antibacterial Handsoap

Active Ingredient: Chloroxylenol 0.5%

Instant foam lathers fast • Mild, pH-balanced formula

Fresh, clean fragrance

KAY® Foaming Antibacterial Handsoap is a rich lather hand soap

with a balanced blend of cleaning agents and skin protecting

moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Manufactured by: Ecolab Inc

1 Ecolab Place · St. Paul, MN 55102 USA

Customer Service: (800) 529-5458

©2025 Kay Chemical Company

All rights reserved | Made in USA

KUSA 785111/8000/0925


Advanced Ingredient Data


Raw Label Data

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