Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 106a2d6a-aa0e-482e-98df-235f731a8cfc
Route
TOPICAL
Published
Effective Date 2025-12-30
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 Hydroxyethyl Cellulose (3000 Mpa.s At 1%) Glycerin Coco-glucoside Glyceryl Oleate Sodium Glycolate Sodium Hydroxide Edetate Trisodium Edetate Disodium Sodium Citrate 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 2016-07-28

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, Hydroxyethylcellulose, Glycerin, Coco-glucoside, Glyceryl Oleate, fragrance, sodium glycolate, Sodium Hydroxide, Trisodium EDTA, Disodium EDTA, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40, Yellow 5, Red 33

Warnings
For external use only.
Directions

• Wet hands and forearms • Apply 5 ml (teaspoonful) or palmful to hands and forearms • Rub vigorously for 20 seconds • Wash between fingers, around fingernails and backs of hands • Rinse thoroughly with warm water  Dry with paper towels or air-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, call 866.897.8061
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 Physician If
  • Skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label

Member's Mark

COMMERCIAL

ANTIBACTERIAL 

HAND SOAP

  • KILLS 99.9% OF GERMS*
  • FRESH, CLEAN FRAGRANCE
  • TRICLOSAN FREE

NET CONTENTS 1 GALLON (3.78 L)

Ecolab 4050 Corporate Drive, Ste. 100

Grapevine, Texas 76051 USA - 866.999.7484

(c) 2020 Ecolab USA Inc. All rights reserved

DISTRIBUTED BY SAM'S WEST, INC.

BENTONVILLE, AR 72716


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, Hydroxyethylcellulose, Glycerin, Coco-glucoside, Glyceryl Oleate, fragrance, sodium glycolate, Sodium Hydroxide, Trisodium EDTA, Disodium EDTA, Sodium Citrate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40, Yellow 5, Red 33

Purpose

Antiseptic handwash

Warnings
For external use only.
Directions

• Wet hands and forearms • Apply 5 ml (teaspoonful) or palmful to hands and forearms • Rub vigorously for 20 seconds • Wash between fingers, around fingernails and backs of hands • Rinse thoroughly with warm water  Dry with paper towels or air-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)
  • For emergency medical information, call 866.897.8061
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 Physician If (Stop use and ask a physician if)
  • Skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Label (Principal display panel and representative label)

Member's Mark

COMMERCIAL

ANTIBACTERIAL 

HAND SOAP

  • KILLS 99.9% OF GERMS*
  • FRESH, CLEAN FRAGRANCE
  • TRICLOSAN FREE

NET CONTENTS 1 GALLON (3.78 L)

Ecolab 4050 Corporate Drive, Ste. 100

Grapevine, Texas 76051 USA - 866.999.7484

(c) 2020 Ecolab USA Inc. All rights reserved

DISTRIBUTED BY SAM'S WEST, INC.

BENTONVILLE, AR 72716


Advanced Ingredient Data


Raw Label Data

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