MEDICATION FILLED SWAB - lidocaine hydrochloride   
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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Drug fact

Antiseptic Swab:

Active Ingredient

Lidocaine 1%                                 for pain relief

Benzalkonium Chloride 0.11%         for antiseptic

Drug Fact

Povidone Iodine Swab:

Active Ingredient

Povidone Iodine 10%, equal to avilable Iodine 1% for antiseptic




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

Keep out of reach of children


           Direction Do not use if label seal is broken prior to purchase.

  • Hold the swab vertically, with the color band tip upwards. Hold in the center of the stem with one hand and at teh color band with the other.
  • Bend the tip at the color band to one side until it snaps.
  • Apply the product to the affected area.
  • Discard swab after use.


Warning

For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs. Do not insert in ear canal. Keep at room temperature. Avoid direct sunlight.

Do not use. If you are sensitive to any product ingredients. in the eyes. Longer than one week unless directed by a doctor.
Stop use and ask a doctor.

Stop use and ask a doctorif If you have deep or puncture wounds, or serious burns. redness,irritation, swelling or pain continue or increas., infedtion occurs.         


For adult and children 2 and older: Clean affected area. Apply 1 to 3 times daily. May be covered with a bandage.

Children under 2 years of age: Consult a doctor.

Antiseptic Swab: Dizolidinyl Urea, Methylparaben, Propylparaben, Water

Providone Iodine Swab: Glycerin, Water


Image of first aid carton label

Image of first aid carton label

MEDICATION FILLED SWAB 
lidocaine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-000
Packaging
#Item CodePackage Description
1NDC:65734-000-231 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 2 mL
Part 21 PACKET 2 mL
Part 1 of 2
ANTISEPTIC SWAB 
lidocaine hydrochloride liquid
Product Information
Item Code (Source)NDC:65734-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine Hydrochloride (Lidocaine) Lidocaine10 mg  in 1 mL
Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Diazolidinyl Urea 
Methylparaben 
Propylparaben 
Propylene Glycol 
Packaging
#Item CodePackage Description
1NDC:65734-125-021 in 1 CARTON
1NDC:65734-125-012 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/01/2003
Part 2 of 2
POVIDONE-IODINE SWAB 
povidone-iodine liquid
Product Information
Item Code (Source)NDC:65734-119
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (Iodine) Iodine10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Hydroxide 
Glycerin 
Water 
Packaging
#Item CodePackage Description
1NDC:65734-119-021 in 1 CARTON
1NDC:65734-119-012 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549manufacture, repack, relabel

Revised: 06/2012
 
Swabplus Inc.