drug facts

drug facts
SPL v1
SPL
SPL Set ID 178b35e0-9024-4d42-b32c-e07d53ef8f5a
Route
topical
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (0.5 mg)
Inactive Ingredients
water potassium cocoate hexylene glycol sodium sulfate anhydrous edetate sodium sodium lauryl sulfate hydroxyethyl cellulose (3000 mpa.s at 1%) glycerin decyl glucoside 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 2025-12-12
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 hands and forearms.
  • Apply 5 ml (teaspoonful) or palmful to hands and forearms.
  • Scrub thoroughly for 20 seconds.
  • Rinse and repeat.
Other Information
  • For additional information, see Material Safety Data Sheet (MSDS)
  • For emergency medical information in USA call (877) 231-2615 or call collect 0 (952)853-1713.
Inactive Ingredients

water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerine, coco glucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red 40, FD&C Yellow 5, D&C Red 33.

Description

Chloroxylenol 0.5%

Questions?

Call 1-800-529-5458

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.
Stop Use and Ask A Doctor If
  • Skin irritation and redness occurs for more than 72 hours.
Principal Display Panel Representative Label

McD

Anti-Microbial

Handwash (AMH)

FOR INSTITUTIONAL USE ONLY

(Chloroxylenol 0.5%)

1 US gal (3.8L)

ECOLAB

KAY CHEMICAL COMPANY -  8300 Capital Drive -  Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

Made in USA

Structured Label Content

Warnings
  • For external use only

Uses
  • For handwashing to decrease bacteria on the skin.
Purpose

Antiseptic handwash

Directions
  • Wet hands and forearms.
  • Apply 5 ml (teaspoonful) or palmful to hands and forearms.
  • Scrub thoroughly for 20 seconds.
  • Rinse and repeat.
Other Information (Other information)
  • For additional information, see Material Safety Data Sheet (MSDS)
  • For emergency medical information in USA call (877) 231-2615 or call collect 0 (952)853-1713.
Inactive Ingredients (Inactive ingredients)

water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerine, coco glucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red 40, FD&C Yellow 5, D&C Red 33.

Questions?

Call 1-800-529-5458

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.
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 Representative Label (Principal Display Panel - Representative Label)

McD

Anti-Microbial

Handwash (AMH)

FOR INSTITUTIONAL USE ONLY

(Chloroxylenol 0.5%)

1 US gal (3.8L)

ECOLAB

KAY CHEMICAL COMPANY -  8300 Capital Drive -  Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

Made in USA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:43.259040 · Updated: 2026-03-14T23:11:28.912883