Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a8da9166-8984-4ca3-bfe5-e1585c7f1ff0
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 Lauryl Sulfate Sodium Sulfate Anhydrous Edetate Sodium Hydroxyethyl Cellulose (3000 Mpa.s At 1%) Glycerin Coco Glucoside Anhydrous Citric Acid Methylchloroisothiazolinone Fd&c Red No. 40 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

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

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 53413-1

Questions?  Call 1-800-529-5458

Warnings
For external use only.
Directions
  • Wet skin and spread a small amount on hands and forearms
  • Scrub well, rinse thoroughly 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.
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 (CI 16035), FD&C Yellow #5 (CI 19140), D&C Red #33 (CI 17200)

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

QSR

Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

Net Contents: 42 USA fl oz (1250 mL)

Distributed by:

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2016 Kay Chemical Company

All rights reserved

758210-01 • KUSA 758210/8001/0416


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 53413-1 (53413-1)

Questions?  Call 1-800-529-5458

Purpose

Antiseptic handwash

Warnings
For external use only.
Directions
  • Wet skin and spread a small amount on hands and forearms
  • Scrub well, 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 Safety Data Sheet (SDS)
  • Medical Emergency:  (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, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red #40 (CI 16035), FD&C Yellow #5 (CI 19140), D&C Red #33 (CI 17200)

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

QSR

Antibacterial Hand Soap

KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

Chloroxylenol 0.5%

Net Contents: 42 USA fl oz (1250 mL)

Distributed by:

Kay Chemical Company · 8300 Capital Drive

Greensboro, NC 27409-9790 USA

Customer Service: (800) 529-5458

©2016 Kay Chemical Company

All rights reserved

758210-01 • KUSA 758210/8001/0416


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)