Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fd68be91-1e90-4c1b-8145-c78baa9f3cd3
Route
TOPICAL
Published
Effective Date 2025-12-17
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 Anhydrous Edetate Sodium Sodium Lauryl Sulfate Glycerin Anhydrous Citric Acid Coco-glucoside Glyceryl Oleate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5 Fd&c Red No. 4

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

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, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FDC Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1

Questions?  Call 1-800-529-5458

Warnings
  • For external use only

Directions
  • Wet hands and forearms • Apply palmful of to hands and forearms
  • Scrub thoroughly • Rinse and dry
Do Not Use
  • In eyes

Active Ingredient

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
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

Kay®

Peel Here For Drug Facts

McD® Foaming

Antibacterial Hand Soap

Instant foam lathers fast •Mild, pH-balanced formula •Fresh, clean fragrance

McD® Foaming Antibacterial Hand Soap is a rich lather hand soap with a balanced blend of cleaning agents and skin protecting moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

To obtain Spanish Instructions, see outer carton.

Net contents: 42 US fl oz (1250 mL)

Distributed by:

KAY CHEMICAL COMPANY•8300 Capital Drive

Greensboro, NC 27409-9790, USA

Customer Service:  (800) 529-5458

®2015 Kay Chemical Company

All rights reserved

763982-00•McDUSA 763982/8000/1115


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, citric acid, coco-glucoside, glyceryl oleate, fragrance, methylchloroisothiazolinone, CI 19140 (FDC Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

Section 53413-1 (53413-1)

Questions?  Call 1-800-529-5458

Purpose

Antiseptic Handwash

Warnings
  • For external use only

Directions
  • Wet hands and forearms • Apply palmful of to hands and forearms
  • Scrub thoroughly • Rinse and dry
Do Not Use (Do not use)
  • In eyes

Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713
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)

Kay®

Peel Here For Drug Facts

McD® Foaming

Antibacterial Hand Soap

Instant foam lathers fast •Mild, pH-balanced formula •Fresh, clean fragrance

McD® Foaming Antibacterial Hand Soap is a rich lather hand soap with a balanced blend of cleaning agents and skin protecting moisturizers.

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

To obtain Spanish Instructions, see outer carton.

Net contents: 42 US fl oz (1250 mL)

Distributed by:

KAY CHEMICAL COMPANY•8300 Capital Drive

Greensboro, NC 27409-9790, USA

Customer Service:  (800) 529-5458

®2015 Kay Chemical Company

All rights reserved

763982-00•McDUSA 763982/8000/1115


Advanced Ingredient Data


Raw Label Data

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