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Hand Sanitizer by Safetec of America, Inc.

Dosage form: liquid
Ingredients: benzalkonium chloride 1.00mg in 1L
Labeler: Safetec of America, Inc.
NDC Code: 61010-8400

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.

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

For external use only.

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

Stop use and ask doctor if irritation or redness develop, or if condition persists for more than 72 hours.

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

Directions
  • Pump a small amount of foam in to palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together briskly until dry

Inactive ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 275 Gal. Container Label

NDC 61010-8400-1

Safetec

Benzalkonium Chloride

Foaming
Hand Sanitizer
Alcohol-Free

SAFETEC OF AMERICA, Inc.
887 Kensington Ave. Buffalo, NY 14215
800-456-7077 www.safetec.com

Reorder no. 37409

275 Gal. (1,041 L)

HAND SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (benzalkonium) benzalkonium chloride1.00 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
water 
cetrimonium chloride 
laurtrimonium chloride 
dihydroxyethyl cocamine oxide 
glycereth-17 cocoate 
citric acid monohydrate 
Packaging
#Item CodePackage Description
1NDC:61010-8400-11041 L in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/14/2014
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-8400)

Revised: 01/2014
 
Safetec of America, Inc.

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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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