Cold Sore Treatment

Manufacturer
H and P Industries, Inc. dba Triad Group
Effective date
2009-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:57

Label at a glance#

ProductCold Sore Treatment
Active ingredientBenzalkonium chloride
Label structure9 sections

Indications and uses

Treat cold sores / fever blisters Help guard against infection

Dosage and administration

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 ho...

Storage and handling

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride, 0.13%

PURPOSE

OTC - PURPOSE SECTION

Cold Sore / Fever Blister Treatment; Topical Antiseptic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor if

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

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

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

isopropyl alcohol (70% v/v), water

PACKAGE INFORMATION - TRIFOLD INNER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

trifold inner
trifold inner

PACKAGE INFORMATION - TRIFOLD OUTER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50730-1001-1


CARE ONE  

1 DAY, 1 DOSE AND HEALING BEGINS
COLD SORE
TREATMENT

Benzalkonium Chloride, 0.13%

COLD SORE/FEVER BLISTER TREATMENT

Treats most cold sores in just one treatment
Patented applicator eliminates need to touch sore with fingers
No Messy creams or ointments left on the face
Instrucciones en espanol incluido


2 Vials
0.6 ml each

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

*Viroxyn is a registered trademark of Quadex Pharmaceuticals LLC.

Distributed by: American Sales Company
4201 Walden Avenue
Lancaster, NY 14086
S and S Brands, Inc.
www.Care1.info

Quality Guaranteed or your money back.
Made in U.S.A.

A 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.
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.

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.

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50730-1001-12019-10-21C16284748780-1956f9ecf-c2e2-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50730-1001-1Cold Sore Treatment2 in 1 PACKAGETINCTURE21
50730-1001-1Cold Sore Treatment0.6 mL in 1 VIAL, PATENT DELIVERY SYSTEMTINCTURE0.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50730-1001COLD SORE TREATMENT (BENZALKONIUM CHLORIDE) TINCTURE [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]1Legacy NDC, 2 package rows20091209_8daf4144-65b3-42cf-a2f8-4ebc47baf2d1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W71
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
isopropyl alcoholINACTIVE INGREDIENTND2M4163021
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50730-100150730-1001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
12b9b3c5-5a05-4595-87bc-cc53bcbf1fd78daf4144-65b3-42cf-a2f8-4ebc47baf2d12009-12-09WarningsExact identifier
spl id: 12b9b3c5-5a05-4595-87bc-cc53bcbf1fd7
spl set id: 8daf4144-65b3-42cf-a2f8-4ebc47baf2d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.