drug facts

drug facts
SPL v6
SPL
SPL Set ID f8016b32-061c-493c-8285-337f309f4a83
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 hydroxyethyl cellulose (3000 mpa.s at 1%) glycerin coco-glucoside glyceryl oleate anhydrous citric acid 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 2015-08-03

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 and spread a small amount on hands and forearms
  • Scrub well, rinse thoroughly and dry
Other Information
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATION: 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 50569-3

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

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, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33

Section 53413-1

Questions? call 1.866.444.7450

Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol 0.5%

When Using This Product
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Representative Label and Principal Display Panel

MONOGRAM

CLEANING DISPOSABLES

CLEAN FORCE®

ANTIBACTERIAL HAND SOAP

648500

Hand care

8000181

25 FL OZ (750 mL)

H17

Active Ingredient: Chloroxylenol 0.5%

For questions or comments, call 1-866-444-7450.

 Manufactured by (c) 2020 Ecolab  Distributed by 
Ecolab - 1 Ecolab  USA Inc - All rights  US Foods 
Place - St. Paul MN  reserved  Rosemont, IL 
55102 USA  Made in U.S.A.  60018 USA 


Structured Label Content

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

Antiseptic handwash

Directions
  • Wet skin and spread a small amount on hands and forearms
  • Scrub well, rinse thoroughly and dry
Other Information (Other information)
  • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
  • EMERGENCY HEALTH INFORMATION: 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 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

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, methylchloroisothiazolinone, methylisothiazolinone, FD&C red #40, FD&C yellow #5, D&C red #33

Section 53413-1 (53413-1)

Questions? call 1.866.444.7450

Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

When Using This Product (When using this product)
  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develop
Representative Label and Principal Display Panel (Representative label and principal display panel)

MONOGRAM

CLEANING DISPOSABLES

CLEAN FORCE®

ANTIBACTERIAL HAND SOAP

648500

Hand care

8000181

25 FL OZ (750 mL)

H17

Active Ingredient: Chloroxylenol 0.5%

For questions or comments, call 1-866-444-7450.

 Manufactured by (c) 2020 Ecolab  Distributed by 
Ecolab - 1 Ecolab  USA Inc - All rights  US Foods 
Place - St. Paul MN  reserved  Rosemont, IL 
55102 USA  Made in U.S.A.  60018 USA 


Advanced Ingredient Data


Raw Label Data

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