3-STEP FIRST AID KIT- povidone-iodine, lidocaine hydrochloride, benzalkonium chloride 
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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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

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

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 DescriptionMarketing Start DateMarketing End Date
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 AND ANESTHETIC SWAB 
lidocaine hydrochloride, benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:65734-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS100 mg  in 10 mL
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride11 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Hydroxide (UNII: 55X04QC32I)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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.876441549repack(65734-000) , manufacture(65734-125, 65734-119)

Revised: 3/2013
Document Id: fff42904-fe50-4b45-ab9b-87ba73b35328
Set id: 4f2dc3fe-9388-4a31-8eff-cfdb2d3501fb
Version: 11
Effective Time: 20130318
 
Swabplus Inc.