Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cfab744b-8cc2-4440-ab44-5052e5352416
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 Edetate Sodium Sodium Lauryl Sulfate Glycerin Anhydrous Citric Acid Glyceryl Oleate Sodium Glycolate Caprylyl/capryl Oligoglucoside Lauryl Glucoside Magnesium Nitrate Sodium Hydroxide Methylchloroisothiazolinone Magnesium Chloride Fd&c Yellow No. 5 Methylisothiazolinone Fd&c Red No. 4

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.

Section 51727-6

Inactive ingredients Water (Aqua), Potassium Cocoate, Hexylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Sodium lauryl sulfate, Glycerin, Sodium Citrate, Glyceryl Oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, Lauryl Glucoside, Magnesium Nitrate, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Yellow 5, Methylisothiazolinone, Red 4

Section 53413-1

Questions? call 1.800.529-5458

Warnings

For external use only

Directions
  • wet hands and forearms
  • dispense a palmful 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)
  • 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
Principal Display Panel and Representative Label

CHEMSTAR 

Foaming Antibacterial 

Hand Soap

KEEP OUT OF REACH OF CHILDREN

Chloroxylenol 0.5%

Net Contents 42 US fl ox (1250 mL)

111280

Distributed by: Kay Chemical Company

8300 Capital Drive - Greensboro, NC 27409

Made in USA

CSUSA 779394/8000/0621


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, Sodium Citrate, Glyceryl Oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, Lauryl Glucoside, Magnesium Nitrate, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Yellow 5, Methylisothiazolinone, Red 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 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 (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • 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
Principal Display Panel and Representative Label (Principal display panel and representative label)

CHEMSTAR 

Foaming Antibacterial 

Hand Soap

KEEP OUT OF REACH OF CHILDREN

Chloroxylenol 0.5%

Net Contents 42 US fl ox (1250 mL)

111280

Distributed by: Kay Chemical Company

8300 Capital Drive - Greensboro, NC 27409

Made in USA

CSUSA 779394/8000/0621


Advanced Ingredient Data


Raw Label Data

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