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

3-Step First Aid Kit by

Drug Labeling and Warnings

3-Step First Aid Kit by is a Otc medication manufactured, distributed, or labeled by Swabplus Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-000-23	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	2 mL
Part 2	1 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 Administration	TOPICAL

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-125-01	2 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/01/2003

Part 2 of 2

POVIDONE-IODINE SWAB 
povidone-iodine liquid

Product Information
Item Code (Source)	NDC: 65734-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Iodine	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Hydroxide (UNII: 55X04QC32I)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-119-01	2 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/01/2003

Labeler - Swabplus Inc. (876441549)

Registrant - Swabplus Inc. (876441549)

Establishment
Name	Address	ID/FEI	Business Operations
Swabplus Inc.		876441549	repack(65734-000) , manufacture(65734-125, 65734-119)