ANTISEPTIC- benzalkonium chloride liquid 
Safetec of America

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.

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Antiseptic

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

First Aid Antiseptic

Uses

Warnings

For external use only.

Do not use in the eyes. If this happens, rinse thoroughly with water.

Stop use and ask doctor if irritation or redness develop and persist 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

Inactive ingredients

Purified water

PRINCIPAL DISPLAY PANEL – pouch label

Safetec

Benzalkonium Chloride
Antiseptic
Towelette

For Professional and Hospital Use

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL – pouch label

PRINCIPAL DISPLAY PANEL – box label

NDC 61010-7100-1

Safetec

Benzalkonium Chloride
Antiseptic
Towelette

For Professional and Hospital Use

Contents: 100 single-use, premoistened towelettes

Reorder No. 37400

PRINCIPAL DISPLAY PANEL – box label
ANTISEPTIC 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-7100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.30 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-7100-1100 in 1 BOX
10.0025 L in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/05/2011
Labeler - Safetec of America (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 5/2011
Document Id: 8acf1da5-9b48-4f06-a454-f0d7700da6cd
Set id: 5a0bfe47-2d06-4d1b-b9d9-7d8bf44d1ab0
Version: 1
Effective Time: 20110505
 
Safetec of America