Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 40342279-c73d-4644-8569-2b44982149e2
Route
TOPICAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Fd&c Blue No. 1 Potassium Citrate Peg-12 Dimethicone (300 Cst) Glyceryl Mono- And Dicaprylocaprate Methyl Gluceth-20 Myristic Diisopropanolamide Anhydrous Citric Acid Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Phenoxyethanol Myristamine Oxide Cocamidopropyl Pg-dimonium Chloride Phosphate Glycerin Polyethylene Glycol 8000 Hexylene Glycol Water Cocamine Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-07-29 Until 2021-09-24

Description

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 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), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, glyceryl caprylate/caprate, PEG-12 dimethicone, potassium citrate, fragrance, FD&C blue 1

Section 53413-1

Questions? call 866.999.7484

Warning
For external use only
Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information, call 866.897.8061
When Using the 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
Representative Label and Principal Display Panel

Member's Mark

COMMERCIAL

FOAMING

ANTIBACTERIAL

HAND SOAP

Available at Sam's Club and samsclub.com

Net 33.8 fl. oz. (1000 ml)

766173-00 766173/5002/0820

ECOLAB • 4050 Corporate Drive STE 100

Grapevine, TX 76051

© 2020 Ecolab • Ecolab USA Inc., All rights reserved.


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), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, glyceryl caprylate/caprate, PEG-12 dimethicone, potassium citrate, fragrance, FD&C blue 1

Section 53413-1 (53413-1)

Questions? call 866.999.7484

Purpose

Antiseptic handwash

Warning
For external use only
Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinse thoroughly and dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information, call 866.897.8061
When Using the Product (When using the 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
Representative Label and Principal Display Panel

Member's Mark

COMMERCIAL

FOAMING

ANTIBACTERIAL

HAND SOAP

Available at Sam's Club and samsclub.com

Net 33.8 fl. oz. (1000 ml)

766173-00 766173/5002/0820

ECOLAB • 4050 Corporate Drive STE 100

Grapevine, TX 76051

© 2020 Ecolab • Ecolab USA Inc., All rights reserved.


Advanced Ingredient Data


Raw Label Data

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