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 Type HUMAN OTC DRUG Item Code (Source) NDC:65734-270
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 100 mg  in 10 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 11 mg  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Product Characteristics
Color white (Colorless) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65734-270-72 72 in 1 PACKET
1 NDC:65734-270-00 0.15 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc (876441549)
Establishment
Name Address ID/FEI Business Operations
Swabplus Inc 876441549 manufacture(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.