Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4a63e543-7a82-4641-b18a-1e07a435383c
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 Edetate Sodium Sodium Lauryl Sulfate Glycerin Caprylyl/capryl Glucoside Lauryl Glucoside Fd&c Red No. 40 Methylchloroisothiazolinone Fd&c Yellow No. 5 Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-30

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 51727-6

Inactive ingredients water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, caprylyl/capryl glucoside, fragrance, lauryl glucoside, red 40, methylchloroisothiazolinone, yellow 5, methylisothiazolinone

Section 53413-1

Questions?  Call 1-800-529-5458

Warnings
  • For external use only

Directions
  • Wet hands to remove soil
  • Dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 877 231 2615. If located outside the United States and Canada, call collect 952 853 1713 (number is in the US).
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
  • Skin irritation or redness occurs for more than 72 hours
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel and Representative Label

ECOLAB

Kay RTU Foaming AB Hand Soap

Active Ingredient: Chloroxylenol 0.5%

1200 mL

(40.6 US FL OZ)

1112847

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2025 Kay Chemical Company

All rights reserved

KUSA · 783800/8000/0225


Structured Label Content

Uses
  • for handwashing to decrease bacteria on the skin.
Section 51727-6 (51727-6)

Inactive ingredients water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, caprylyl/capryl glucoside, fragrance, lauryl glucoside, red 40, methylchloroisothiazolinone, yellow 5, methylisothiazolinone

Section 53413-1 (53413-1)

Questions?  Call 1-800-529-5458

Purpose

Antiseptic Handwash

Warnings
  • For external use only

Directions
  • Wet hands to remove soil
  • Dispense palmful
  • spread to cover hands, rub in well
  • air dry, do not rinse or towel dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 877 231 2615. If located outside the United States and Canada, call collect 952 853 1713 (number is in the US).
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)
  • Skin irritation or redness occurs for more than 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

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

ECOLAB

Kay RTU Foaming AB Hand Soap

Active Ingredient: Chloroxylenol 0.5%

1200 mL

(40.6 US FL OZ)

1112847

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2025 Kay Chemical Company

All rights reserved

KUSA · 783800/8000/0225


Advanced Ingredient Data


Raw Label Data

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