ANTIBACTERIAL- benzalkonium chloride soap 
Rubbermaid Commercial Products LLC

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

  • 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.)

PRINCIPAL DISPLAY PANEL - 800 mL Bottle Label
ANTIBACTERIAL 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65321-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65321-031-01800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/2017
2NDC:65321-031-021600 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/24/2017
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/FEIBusiness Operations
Abaco Partners LLC DBA Surefil964809417MANUFACTURE(65321-031)

Revised: 10/2019
Document Id: 6c81d310-d365-4ea3-ae82-cc1048fcfc94
Set id: 6023285c-6b02-410e-9492-df0543279f25
Version: 4
Effective Time: 20191025
 
Rubbermaid Commercial Products LLC