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3-Step First Aid Kit by Swabplus Inc.

Dosage form: kit
Ingredients: LIDOCAINE HYDROCHLORIDE 100mg in 10mL, Benzalkonium Chloride 11mg in 10mL; Povidone-Iodine 100mg in 10mL
Labeler: Swabplus Inc.
NDC Code: 65734-000

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.

3 Step First Aid Kit Medication Filled Swabs

Drug Facts
Active Ingredients

Antiseptic Swabs

Lidocaine Hydrochloride 1.0%

Benzalkonium Chloride 0.11%

Povidone Iodine swabs:

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

Purpose

Lidocaine Hydrochloride for Pain Relief

Benzalkonium Chloride for Antiseptic

Povidone Iodine for Antiseptis

Uses

First aid to help prevent infection, and temporarily reliever pain and itching associated with minor cuts. scrapes and burn

Keep out of reach of children

Keeo out of reach of children

Directions
  • Do not use if label seal is broken prior to purchase.
  • Hold the swab vertically, with the color ring band tip upwards. Hold in the center of the stem with one hand and at the 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.

Warnings

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

Do not use. Swabs 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 if you have deep or punchture wounds, or serious burns. redness, irritation, sweeling or pain continues or increases, infection occurs

Other information

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.

Avoid storing at excessive heat.

Inactive Ingredients

Antiseptic swab: Dizolidinyl Urea, Methylparaben, Propylparaben, Water

Providone Iodine Swab: Glcerin, Water

Manufacturer Statement

Soft cotton tip swabs individually filled with Antiseptic or Iodine. Ready to use and convenient to carry for fast, clean, safe first aid.

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

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

Package and label

Image of first aid carton label

3-STEP FIRST AID KIT 
povidone-iodine, lidocaine hydrochloride, benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-000
Packaging
#Item CodePackage Description
1NDC:65734-000-231 KIT 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 AND ANESTHETIC SWAB 
lidocaine hydrochloride, benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:65734-125
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 
Packaging
#Item CodePackage Description
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) Iodine100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Hydroxide 
Glycerin 
Water 
Packaging
#Item CodePackage Description
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/FEIOperations
Swabplus Inc.876441549repack(65734-000), manufacture(65734-125, 65734-119)

Revised: 03/2013
 
Swabplus Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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