Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID de3b8c33-0d6c-49a9-8243-0d52284770f4
Route
TOPICAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (8.9 mg)
Inactive Ingredients
Water Cocamine Oxide Glycerin Cocamidopropyl Pg-dimonium Chloride Phosphate Hexylene Glycol Methyl Gluceth-20 Peg-7 Glyceryl Cocoate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Lactic Acid Edetate Sodium Peg-12 Dimethicone (300 Cst) Glycereth-18 Ethylhexanoate Glycereth-18 D&c Red No. 33 Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-26

Description

Benzalkonium chloride 0.89%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.89%

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 50569-3

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6

Inactive ingredients water (aqua), cocamine oxide, glycerin, cocamidopropyl pg-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, polyquaternium-77, lactic acid, tetrasodium EDTA, PEG-12 dimethicone, glycereth-18 ethylhexanoate, glycereth-18, polyquaternium-7, fragrance, red 33, methylchloroisothiazolinone, methylisothiazolinone

Section 53413-1

Questions? call  1800-35-CLEAN (352-5326)

Warnings
For external use only
Directions

Do not mix with anything except for potable water.

Use bottle labeled for this product only for mixing and dispensing product.

  • open dispenser, place bottle into position, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.89%

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 in the US).
When Using This Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Directions: Ready to Use Solution
  • wet hands with warm water
  • apply soap to hands and scrub vigorously
  • wash between fingers, around fingernails, and back of hands
  • rinse hands thoroughly with warm water
  • dry hands with clean towel or with mechanical dryer
Principal Display Panel and Representative Label

ECOLAB  6102662

FACILIPRO

Concentrated

Antibacterial

Foaming

Hand Soap

1.9L (64 US FL OZ)

Active ingredeint: Benzalkonium chloride 0.89%

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

© 2024 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

782560/5400/0324


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 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

Section 51727-6 (51727-6)

Inactive ingredients water (aqua), cocamine oxide, glycerin, cocamidopropyl pg-dimonium chloride phosphate, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, polyquaternium-77, lactic acid, tetrasodium EDTA, PEG-12 dimethicone, glycereth-18 ethylhexanoate, glycereth-18, polyquaternium-7, fragrance, red 33, methylchloroisothiazolinone, methylisothiazolinone

Section 53413-1 (53413-1)

Questions? call  1800-35-CLEAN (352-5326)

Purpose

Antiseptic handwash

Warnings
For external use only
Directions

Do not mix with anything except for potable water.

Use bottle labeled for this product only for mixing and dispensing product.

  • open dispenser, place bottle into position, and close dispenser
  • fill hand soap bottle with solution from dispenser
  • place bottle into a Nexa dispenser for use
Do Not Use (Do not use)
  • in eyes
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.89%

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 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
Directions: Ready to Use Solution (Directions: Ready-To-Use Solution)
  • wet hands with warm water
  • apply soap to hands and scrub vigorously
  • wash between fingers, around fingernails, and back of hands
  • rinse hands thoroughly with warm water
  • dry hands with clean towel or with mechanical dryer
Principal Display Panel and Representative Label (Principal display panel and representative label)

ECOLAB  6102662

FACILIPRO

Concentrated

Antibacterial

Foaming

Hand Soap

1.9L (64 US FL OZ)

Active ingredeint: Benzalkonium chloride 0.89%

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

© 2024 Ecolab USA Inc. · All rights reserved

Made in U.S.A.

782560/5400/0324


Advanced Ingredient Data


Raw Label Data

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