Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 5deb8aba-fe98-4390-a7a2-c9ca9348df3c
Route
TOPICAL
Published
Effective Date 2009-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mL)
Inactive Ingredients
Isopropyl Alcohol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-06-01

Description

Benzalkonium chloride, 0.13%

Purpose

Cold Sore / Fever Blister Treatment; Topical Antiseptic


Medication Information

Warnings and Precautions



Purpose
Cold Sore / Fever Blister Treatment; Topical Antiseptic

Description

Benzalkonium chloride, 0.13%

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

Section 42229-5



Section 50568-5



Section 53413-1



Section 53414-9



Warnings

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

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.
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.

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

Active Ingredient
Benzalkonium chloride, 0.13%

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
When Using This Product
you may feel a brief stinging sensation when applying it. The sting should go away in a short time.

Stop Use and Ask A Doctor If
  • condition persists or worsens
  • symptoms persist for more than 7 days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Information Trifold Inner
1. CLEAN AREA



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 VIAL



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 he applicator.

If necessary: pinch vial gently until a drop of medication appears.



Prior to use:

Remove vial from package



3. RUB ON LIPS



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

Walgreens                NDC 50730-1000-1



FAST RELIEF

COLD SORE

TREATMENT




Cold Sore/Fever Blister Treatment

and Topical Antiseptic



*Viroxyn Recommended by Dentists



Single Dose Treatment for Fast Pain Relief



Patented Application

without using fingers



Instrucciones en espanol incluido



2-Single dose ONE DAY Treatment Vials-0.6 ml each



Distributed by: Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed   www.walgreens.com

Questions or comments? 1-800-WALGREENS (1-800-925-4733)



Patented new approach to treating cold sores. Rubbing the cold sore with the applicator tip delivers the germicidal medicine directly to the site of the infection.



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)



Cold Sores and Fever Blisters are both caused by the Herpes Simples virus (typically HSV-1) and are just different popular names for the HSV-caused lesions.



*Viroxyn is a registered trademark of Quadex Labs, Inc.



US Patent No's 6,211,243B1 and 6,322,243 and 6,410,599 and 6,414,032 and 6,423,750 and 6,759,434


Structured Label Content

Uses (USES)
  • Treat cold sores / fever blisters
  • Help guard against infection

Warnings and Precautions (34071-1)



Section 42229-5 (42229-5)



Section 50568-5 (50568-5)



Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Purpose (PURPOSE)
Cold Sore / Fever Blister Treatment; Topical Antiseptic

Warnings (WARNINGS)

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

Directions (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.
Do Not Use (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.

Ask A Doctor If (Ask a doctor if)
  • used to treat deep or puncture wounds, animal bites, or serious burns
  • you are pregnant or nursing a baby

Active Ingredient (ACTIVE INGREDIENT)
Benzalkonium chloride, 0.13%

Other Information (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 (INACTIVE INGREDIENTS)
isopropyl alcohol (70% v/v), water
When Using This Product (When using this product)
you may feel a brief stinging sensation when applying it. The sting should go away in a short time.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition persists or worsens
  • symptoms persist for more than 7 days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Information Trifold Inner (PACKAGE INFORMATION - TRIFOLD INNER)
1. CLEAN AREA



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 VIAL



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 he applicator.

If necessary: pinch vial gently until a drop of medication appears.



Prior to use:

Remove vial from package



3. RUB ON LIPS



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 (PACKAGE INFORMATION - TRIFOLD OUTER)

Walgreens                NDC 50730-1000-1



FAST RELIEF

COLD SORE

TREATMENT




Cold Sore/Fever Blister Treatment

and Topical Antiseptic



*Viroxyn Recommended by Dentists



Single Dose Treatment for Fast Pain Relief



Patented Application

without using fingers



Instrucciones en espanol incluido



2-Single dose ONE DAY Treatment Vials-0.6 ml each



Distributed by: Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed   www.walgreens.com

Questions or comments? 1-800-WALGREENS (1-800-925-4733)



Patented new approach to treating cold sores. Rubbing the cold sore with the applicator tip delivers the germicidal medicine directly to the site of the infection.



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)



Cold Sores and Fever Blisters are both caused by the Herpes Simples virus (typically HSV-1) and are just different popular names for the HSV-caused lesions.



*Viroxyn is a registered trademark of Quadex Labs, Inc.



US Patent No's 6,211,243B1 and 6,322,243 and 6,410,599 and 6,414,032 and 6,423,750 and 6,759,434


Advanced Ingredient Data


Raw Label Data

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