ANTISEPTIC FORMULA FILLED SWAB - lidocaine hydrochloride and benzalkonium chloride liquid 
Swabplus Inc.

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 Formula Filled Swab

Active ingredients

Benzalkonium Chloride 0.11%

Lidocaine Hydrochloride 1.0%

Purpose

Benzalkonium Chloride    for Antiseptic

Lidocaine Hydrochloride   for Pain relief

Uses

Uses First aid to help prevent infection, and temporarily relieve pain and itching associated with minor cuts, scrapes and burns.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Warnings

Administration

Other information

Store at room temperature.Avoid direct sunlight, excessive heat and moistgure.

Inactive ingredients

Dizolidinyl Urea, Methylparaben, Propylparben, water.

Patent

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 Made in USA

The COLOR RING is copyrighted by Swabplus Inc. ©2007 SWABPLUS INC.

Package and Label

Image of antiseptic carton label

Image of antiseptic carton label

ANTISEPTIC FORMULA FILLED SWAB  
lidocaine hydrochloride, benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65734-270
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) LIDOCAINE HYDROCHLORIDE ANHYDROUS100 mg  in 10 mL
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE11 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water 
DIAZOLIDINYL UREA 
Methylparaben 
Propylparaben 
Propylene Glycol 
Product Characteristics
Colorwhite (Colorless) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-270-7272 in 1 PACKET
1NDC:65734-270-000.15 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc876441549manufacture(65734-270), relabel(65734-270), repack(65734-270)

Revised: 3/2013
Document Id: 12c48fc2-d20c-40b5-ba67-0087127c27d8
Set id: be27f0c4-6be9-412a-a07a-9e8aa284c2a3
Version: 7
Effective Time: 20130329
 
Swabplus Inc.