Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f7da7470-3fbe-4869-8333-16d2091de53f
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 Sodium Citrate Glyceryl Oleate Sodium Glycolate Decyl Glucoside Lauryl Glucoside Magnesium Nitrate Sodium Hydroxide Methylchloroisothiazolinone Magnesium Chloride Fd&c Yellow No. 5 Methylisothiazolinone Fd&c Red No. 4

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 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, magnesium nitrate, sodium hydroxide, methylchloroisothiazolinone, magnesium chloride, yellow 5, methylisothiazolinone, red 4

Section 53413-1

Questions?  call  1-800-529-5458

Warnings
  • For external use only
Directions
  • wash 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 infomration 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
Principal Display Panel and Representative Label

ECOLAB

Foaming AB Hand Soap

Active Ingredient: Chloroxylenol 0.5%

1200 mL

(40.6 US FL OZ)   1112846

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2024 Kay Chemical Company

All rights reserved

KUSA · 782978/8000/0224


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, magnesium nitrate, sodium hydroxide, methylchloroisothiazolinone, magnesium chloride, yellow 5, methylisothiazolinone, red 4

Section 53413-1 (53413-1)

Questions?  call  1-800-529-5458

Purpose

Antiseptic handwash

Warnings
  • For external use only
Directions
  • wash 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 (Other information)
  • for additional infomration 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
Principal Display Panel and Representative Label (Principal display panel and representative label)

ECOLAB

Foaming AB Hand Soap

Active Ingredient: Chloroxylenol 0.5%

1200 mL

(40.6 US FL OZ)   1112846

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2024 Kay Chemical Company

All rights reserved

KUSA · 782978/8000/0224


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)