Your browser does not support JavaScript! ANTISEPTIC FORMULA FILLED SWAB (LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE) LIQUID [SWABPLUS INC.]
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ANTISEPTIC FORMULA FILLED SWAB (lidocaine hydrochloride, benzalkonium chloride) liquid
[Swabplus Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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

  • Hold the swan vertically, with the color tip upwards. Hold in the center of the tube with one hand and at the color ring with the other.
  • Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
  • Apply the product to the affected area.
  • Discard swab after use.

Warnings

  • For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
  • Do not use. longer than one week unless directed  by a doctor.
  • Stop use and ask a doctor if you have deep or puncture wounds, or serious burns, redness, irritation, swelling or pain continues or increase, infection occurs.

Administration

  • For adult and children 2 and older:Clean affected area and apply 1 to 3 times daily. May be covered with a bandage.
  • Children under 2 years of age: Do not use, consult a doctor. 

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
 
Swabplus Inc.

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