Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a8cfd52e-7108-4d0d-bc47-1f1d17eef9fe
Route
TOPICAL
Published
Effective Date 2025-12-30
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 Coco-glucoside Glyceryl Oleate 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 2025-12-30

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 throughly for 20 seconds
  • Rinse and repeat
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 1-800-391-1504
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, 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 or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

NDC 63149-121-01

LAGARDE™

Antibacterial Hand Soap

Active ingredient

Chloroxylenol 0.5%

SSDC Sustainable Solutions

1 US gallon (3.78 liters)

Distributed by: SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100 • Grapevine, Texas 76051, USA • 800.532.7732

©2013 Kay Chemical Company • All Rights Resevrved

1111917

747932-01 747932/7300/0613


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 throughly for 20 seconds
  • Rinse and repeat
Do Not Use (Do not use)
  • In eyes
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 1-800-391-1504
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, 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 or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

NDC 63149-121-01

LAGARDE™

Antibacterial Hand Soap

Active ingredient

Chloroxylenol 0.5%

SSDC Sustainable Solutions

1 US gallon (3.78 liters)

Distributed by: SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100 • Grapevine, Texas 76051, USA • 800.532.7732

©2013 Kay Chemical Company • All Rights Resevrved

1111917

747932-01 747932/7300/0613


Advanced Ingredient Data


Raw Label Data

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