Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 174e2533-88a4-453d-ad5e-f936c4104c19
Route
TOPICAL
Published
Effective Date 2024-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (10 mg)
Inactive Ingredients
Water Propylene Glycol Urea Sorbitol Potassium Cocoate Edetate Sodium Alcohol Glycerin Sodium Xylenesulfonate Citric Acid Monohydrate Cocamine Oxide Fd&c Yellow No. 5 Fd&c Blue No. 1 Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-21

Description

Chloroxylenol 1.0%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Chloroxylenol 1.0%

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), propylene glycol, urea, sorbitol, potassium cocoate, tetrasodium EDTA, SD alcohol 3-C, glycerin, sodium xylenesulfonate, citric acid, fragrance, cocamine oxide, FDC yellow 5, FDC blue 1

Section 53413-1

Questions? call 1.800.35.CLEAN (352.5326)

Warnings

For external use only

Directions
  • Wet hands and apply foam
  • Scrub hands and forearm
  • Rinse thoroughly and dry
Do Not Use
  • In eyes
Active Ingredient

Chloroxylenol 1.0%

Other Information
  • For additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
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 for 72 hours
Principal Display Panel and Representative Label

ECOLAB®

6100719

Gentle Antibacterial

Foam Hand Soap

750 ML (25 US FL OZ)

Active ingredient: Chloroxylenol 1.0%

755511/5403/0321

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.


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), propylene glycol, urea, sorbitol, potassium cocoate, tetrasodium EDTA, SD alcohol 3-C, glycerin, sodium xylenesulfonate, citric acid, fragrance, cocamine oxide, FDC yellow 5, FDC blue 1

Section 53413-1 (53413-1)

Questions? call 1.800.35.CLEAN (352.5326)

Purpose

Antiseptic handwash

Warnings

For external use only

Directions
  • Wet hands and apply foam
  • Scrub hands and forearm
  • Rinse thoroughly and dry
Do Not Use (Do not use)
  • In eyes
Active Ingredient (Active ingredient)

Chloroxylenol 1.0%

Other Information (Other information)
  • For additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
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 for 72 hours
Principal Display Panel and Representative Label

ECOLAB®

6100719

Gentle Antibacterial

Foam Hand Soap

750 ML (25 US FL OZ)

Active ingredient: Chloroxylenol 1.0%

755511/5403/0321

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

tel: 1 800 35 CLEAN (352 5326)

© 2021 Ecolab USA Inc. · All rights reserved

Made in U.S.A.


Advanced Ingredient Data


Raw Label Data

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