VIROXYN PROFESSIONAL USE- benzalkonium chloride and benzocaine liquid

Viroxyn Professional Use by

Drug Labeling and Warnings

Viroxyn Professional Use by is a Otc medication manufactured, distributed, or labeled by Quadex Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients:	Purposes:
Benzalkonium Chloride 0.3%	Cold Sore/Fever Blister Treatment
Benzocaine 7.5%	Pain Relief During Application

Uses

• To treat cold sores/fever blisters.

Warning

• For external use only.
• Flammable; keep away from fire or flame

Do not use

• In the eyes
• Longer than one week, unless directed by a doctor
• If you are allergic to any ingredient in this product
• Over large areas of the body
• More than 3 times a day

Stop use and ask a doctor if:

• Condition persists or worsens
• Symptoms persist for more than 7-10 days

Ask a doctor if:

• You are pregnant or nursing a baby

When using this product you may feel a brief stinging sensation when you apply it. The sting should go away in a short time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions – Adults and children over 2 years of age

• Using only warm water and a washcloth, clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick.
• Remove the cardboard cap from the applicator end and place the cardboard cap on to the glass/plastic vial end, opposite the brush end of the product.
• Squeeze the cardboard cap to break open the inner glass vial.
• Saturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicator.
• Touch the cold sore with the wet applicator and allow the numbing agent a few moments to numb your lip. Then begin actual treatment.
• For best results, message the solution into the cold sore by rubbing. Rub firmly, but take care not to damage the tissue. The purpose of the rubbing is to deliver the drug to the infection site. Hold the vial so the solution flows to the sore.
• To treat most cold sores, usually one treatment is enough. If you symptoms go away and then return later, apply another dose for the second cold sore.
• Do not use more than 3 times a day.
• Children under 2 years of age – ask a doctor or dentist.
• Discard after use.

Other Information

Store at room temperature. The ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Viroxyn Professional Use®. For best results, avoid brushing your teeth with toothpaste or drinking sodas or fruit juices for at least one hour after applying the drug. Some people may notice a thin white powder on the lips after treatment. This is benzocaine that did not get absorbed into the lip and is normal.

Inactive Ingredients

Isopropyl alcohol (70% v/v), water

QUESTIONS

Questions or to report an adverse event: 1-877-825-7153

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Quadex Labs
6975 Union Park Center #300
Salt Lake City, Utah 84047
www.viroxyn.com
1-877-825-7153

PRINCIPAL DISPLAY PANEL - 2 Vial Carton

NDC: 66774-1003-2

Professional Use
Cold Sore Treatment

Viroxyn®
PROFESSIONAL USE
WITH 7.5%
BENZOCAINE

Cold Sore Treatment

Relieves Pain
Starts Healing
Just One Dose

Available ONLY through medical professionals.

Contents: 2 Vials (0.6 ml)

INGREDIENTS AND APPEARANCE

VIROXYN PROFESSIONAL USE 
benzalkonium chloride and benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66774-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium chloride	1.14 mg  in 1 mL
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)	Benzocaine	65.775 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Alcohol (UNII: ND2M416302)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66774-1003-2	2 in 1 BLISTER PACK
1		0.6 mL in 1 AMPULE
2	NDC: 66774-1003-3	3 in 1 BLISTER PACK
2		0.6 mL in 1 AMPULE
3	NDC: 66774-1003-4	6 in 1 BOX
3		0.6 mL in 1 AMPULE
4	NDC: 66774-1003-5	12 in 1 BLISTER PACK
4		0.6 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/22/2012

Labeler - Quadex Pharmaceuticals LLC (090438909)

Establishment
Name	Address	ID/FEI	Business Operations
Quadex Pharmaceuticals LLC		090438909	MANUFACTURE(66774-1003)