Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a0efcc90-0ba3-4704-ae75-0157ff7727b4
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 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 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, methychloroisothiazolinone, CI 19140 (FD&C 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
  • Dispense a palmful of product to hands
  • Scrub hands and forearms for 20 seconds
  • Rinse thoroughly and dry
Do Not Use
  • In eyes
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
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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel and Representative Label

FORTRESS® Foaming Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY

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

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

To obtain Spanish instructions, see outer carton.

Para obtener las instrucciones en español, véase la caja exterior.

KAY CHEMICAL COMPANY

8300 Capital Drive

Greensboro, NC 27409-3790, USA

Customer Service: (800) 529-5458

706402-04

KUSA 706402/8004/0412

©2012 Kay Chemical Company

All Rights Reserved

25 US fl OZ (750 ml)


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin.

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, methychloroisothiazolinone, CI 19140 (FD&C 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
  • Dispense a palmful of product to hands
  • Scrub hands and forearms for 20 seconds
  • Rinse thoroughly and dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient (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
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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel and Representative Label (Principal display panel and representative label)

FORTRESS® Foaming Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY

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

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

To obtain Spanish instructions, see outer carton.

Para obtener las instrucciones en español, véase la caja exterior.

KAY CHEMICAL COMPANY

8300 Capital Drive

Greensboro, NC 27409-3790, USA

Customer Service: (800) 529-5458

706402-04

KUSA 706402/8004/0412

©2012 Kay Chemical Company

All Rights Reserved

25 US fl OZ (750 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)