ANTISEPTIC FORMULA FILLED SWAB- lidocaine hydrochloride, benzalkonium chloride liquid

Antiseptic Formula Filled Swab by

Drug Labeling and Warnings

Antiseptic Formula Filled Swab by is a Otc medication manufactured, distributed, or labeled by Swabplus Inc., Swabplus Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTISEPTIC FORMULA FILLED SWAB  
lidocaine hydrochloride, benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65734-270
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)

Product Characteristics
Color	white (Colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65734-270-72	72 in 1 PACKET
1	NDC: 65734-270-00	0.15 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2003

Labeler - Swabplus Inc. (876441549)

Registrant - Swabplus Inc (876441549)

Establishment
Name	Address	ID/FEI	Business Operations
Swabplus Inc		876441549	manufacture(65734-270) , relabel(65734-270) , repack(65734-270)