drug facts

drug facts
SPL v6
SPL
SPL Set ID fc3a590c-6955-4496-9bb6-8142a4c15046
Route
topical
Published
Effective Date 2025-12-11
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 hydroxyethyl cellulose (3000 cps at 1%) glycerin coco glucoside glyceryl oleate citric acid monohydrate methylchloroisothiazolinone methylisothiazolinone fd&c red no. 40 fd&c yellow no. 5 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2010-05-26

Purpose

Antiseptic handwash

Description

Chloroxylenol, 0.5%


Medication Information

Warnings
For external use only.
Uses
  • For handwashing to decrease bacteria on the skin.

Purpose

Antiseptic handwash

Directions
  • Wet skin an spread a small amount on hands and forearms
  • Scrub well, rinse thoroughly and dry
Other Information
  • Read Material Safety Data Sheet (MSDS) before using this product
  • Emergency Healthcare Infomration :  1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
Description

Chloroxylenol, 0.5%

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, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methychloroisothiazolinone, methylisothiazolinone, FDC red 40, FDC yellow 5, DC red 33

Section 53413-1

Questions? call 1.800.35.CLEAN (352.5326)

Do Not Use
  • in eyes
Active Ingredient

Chloroxylenol, 0.5%

When Using This Product
  • If in eyes, risne promptly and thorougly with water
  • Discontinue use if irritation and redness develp
Stop Use and Ask A Doctor If
  • Skin irritation and redness occurs for more than 72 hours
Principal Display Panel and Representative Label

KEYSTONE™

Sysco®

LIQUID AB HAND SOAP

Active Ingredient:  Chloroxylenol 0.5%

Sysco® 2545766

6100748 ECOLAB®

750 ML (25 US FL OZ)


Structured Label Content

Warnings
For external use only.
Uses
  • For handwashing to decrease bacteria on the skin.

Purpose

Antiseptic handwash

Directions
  • Wet skin an spread a small amount on hands and forearms
  • Scrub well, rinse thoroughly and dry
Other Information
  • Read Material Safety Data Sheet (MSDS) before using this product
  • Emergency Healthcare Infomration :  1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US)
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, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methychloroisothiazolinone, methylisothiazolinone, FDC red 40, FDC yellow 5, DC red 33

Section 53413-1 (53413-1)

Questions? call 1.800.35.CLEAN (352.5326)

Do Not Use (Do not use)
  • in eyes
Active Ingredient

Chloroxylenol, 0.5%

When Using This Product (When using this product)
  • If in eyes, risne promptly and thorougly with water
  • Discontinue use if irritation and redness develp
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Skin irritation and redness occurs for more than 72 hours
Principal Display Panel and Representative Label

KEYSTONE™

Sysco®

LIQUID AB HAND SOAP

Active Ingredient:  Chloroxylenol 0.5%

Sysco® 2545766

6100748 ECOLAB®

750 ML (25 US FL OZ)


Advanced Ingredient Data


Raw Label Data

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