COLD SORE TREATMENT- benzalkonium chloride tincture

Cold Sore Treatment by

Drug Labeling and Warnings

Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium chloride, 0.13%

PURPOSE

Cold Sore / Fever Blister Treatment; Topical Antiseptic

USES

• Treat cold sores / fever blisters
• Help guard against infection
  

WARNINGS

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

Do not use

• in the eyes
• over large areas of the body
• if you are allergic to any ingredient in the product
• more than 3 times per day
• longer than one week unless directed by a doctor.
  

Stop use and ask a doctor if

• condition persists or worsens
• symptoms persist for more than 7 days
  

Ask a doctor if

• used to treat deep or puncture wounds, animal bites, or serious burns
• you are pregnant or nursing a baby
  

When using this product

you may feel a brief stinging sensation when applying 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:

• Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using warm water and a washcloth
• Remove the cardboard top from applicator and place onto the glass/plastic vial end - opposite the brush end of the product
• Squeeze the cardboard to break the inner glass vial open
• 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
• For best results, massage 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 your symptoms go away and then return later, apply another dose.
  
• Do not use more than 3 times per day
• Discard after use.

Children under 2 years of age: ask a doctor.

SPL UNCLASSIFIED SECTION

OTHER INFORMATION

• Store at room temperature: 15° - 30° C (59° - 86° F)
• The ingredients in toothpaste, softdrinks, and some fruit juices can de-activate the active ingredient. For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying.
  

INACTIVE INGREDIENTS

isopropyl alcohol (70% v/v), water

QUESTIONS

PACKAGE INFORMATION - TRIFOLD INNER

1. CLEAN

Prior to treatment, clean the area to be treated preferably with a washcloth and warm water. A dry wipe may be sufficient. Do not use soap or other cleansers.

2. BREAK

Remove paper cap from vial, exposing applicator tip.
Replace cap on other end of vial, leaving applicator tip exposed.
Firmly pinch center of vial, close to edge of paper cap, until inner ampoule breaks.
Hold with the white applicator tip down, allowing medication to saturate the applicator.
If necessary: pinch vial gently until a drop of medication appears.

Prior to use: Remove vial from package

3. RUB

The key is to rub on the sore and the surrounding area. Gently dabbing is not effective.
Do not rub so hard that you cause damage to the skin.
Keep the applicator saturated at all times. If necessary, pause and hold the vial to allow more medication to flow into the applicator tip.
Use all the medication in the vial.
Dispose of when finished, recap the vial and dispose of immediately. Do not disassemble; keep out of reach of children.

Occasionally an additional treatment may be required. In some people, a lesion may appear to start healing and recur a day or more later. This will require an additional treatment.

PACKAGE INFORMATION - TRIFOLD OUTER

LEADER  SATISFACTION GUARANTEED

NDC: 37205-973-19

Cold Sore
Treatment

Cold Sore / Fever Blister Treatment
Topical Antiseptic

Treats most cold sores in just ONE treatment
Unique patented applicator eliminates need to touch sore with your fingers
No messy creams or ointments left on the face
Single use applicator

Compare to Viroxyn©

2 VIALS (0.6 ml EACH)

Fast Pain Relief

Distributed by Cardinal Health
Dublin, OH 43017 CIN 3924091
www.myleader.com    MADE IN USA

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

US Patent No. 6,211,243B1



A patented new approach (US 6,211,243B1) to treating cold sores - rubbing the cold sore with the applicator tip delivers the germicidal medicine directly to the site of the infection.
Cold Sores and Fever Blisters are both caused by the Herpes Simplex virus (typically HSV-1) and are just different popular names for the HSV-caused lesions.

HERPES IS HIGHLY CONTAGIOUS.

A well-intentioned kiss can transfer the virus to another individual. Children are highly at risk.

After touching a cold sore:

    * Wash your hands immediately with warm water and soap
    * Do not touch your eyes
    * Do not touch your genitals or other parts of the body. It is possible to transfer the virus to other parts of the body (autoinoculation)

Occasionally an additional treatment may be required. In some people, a lesion may appear to start healing and recur a day or more later. This will require an additional treatment.

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT 
benzalkonium chloride tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-973
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium chloride	0.13 mL  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: 37205-973-19	2 in 1 PACKAGE
1		0.6 mL in 1 VIAL, PATENT DELIVERY SYSTEM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/20/2007

Labeler - Cardinal Health (097537435)