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Antibacterial by Rubbermaid Commercial Products LLC

Medically reviewed on July 24, 2017

Dosage form: soap
Ingredients: Benzalkonium Chloride 13mg in 10mL
Labeler: Rubbermaid Commercial Products LLC
NDC Code: 65321-031

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Antibacterial Lotion Soap

Drug Facts

Active Ingredient

0.13% Benzalkonium Chloride

Purpose

Antibacterial Hand Wash

Use

For hand washing to decrease bacteria on skin. Repeat as needed.

Warnings
  • For external use only.

  • When using this product avoid contact with eyes. In case of eye contact, flush with water.

  • Stop use and ask a doctor, if irritation or redness persist.

  • Do not ingest.

  • Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands, place hands under the dispenser to allow 0.8ml of hand wash to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.

Inactive Ingredients

Water, Cetrimonium Chloride, Glycerin, Sodium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazilinone, Methylisothiazilinone.

Questions?

1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

Distributed by Rubbermaid Commercial Products LLC
3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label

Rubbermaid®
Commercial Products

TECHNICAL CONCEPTS

Antibacterial Lotion Soap

To be used with OneShot® liquid dispensers
800mL
(27 FL. OZ.)

ANTIBACTERIAL 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65321-031
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride13 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cetrimonium Chloride 
Glycerin 
Sodium Chloride 
Lauramidopropylamine Oxide 
Coco Monoethanolamide 
PEG-120 Methyl Glucose Dioleate 
Citric Acid Monohydrate 
Edetate Sodium 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:65321-031-01800 mL in 1 BOTTLE, PUMP
2NDC:65321-031-021600 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E07/24/2017
Labeler - Rubbermaid Commercial Products LLC (049924368)
Establishment
NameAddressID/FEIOperations
Abaco Partners LLC DBA Surefil964809417MANUFACTURE(65321-031)

 
Rubbermaid Commercial Products LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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