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
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.

Warnings
  • For external use only

Directions
  • Wet hands and forearms.
  • Apply 5 ml (teaspoonful) or palmful to hands and forearms.
  • Scrub thoroughly for 20 seconds.
  • Rinse and repeat.
Do Not Use
  • In eyes.
Questions?

Call 1-800-529-5458

Active Ingredient

Chloroxylenol 0.5%

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.

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

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.

Purpose

Antiseptic handwash

Warnings
  • For external use only

Directions
  • Wet hands and forearms.
  • Apply 5 ml (teaspoonful) or palmful to hands and forearms.
  • Scrub thoroughly for 20 seconds.
  • Rinse and repeat.
Do Not Use (Do not use)
  • In eyes.
Questions?

Call 1-800-529-5458

Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

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.

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