FDA.reportPublic FDA data

Viroxyn Professional Use

Manufacturer
Quadex Pharmaceuticals LLC
Effective date
2012-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:35

Label at a glance#

ProductViroxyn Professional Use
Active ingredientBenzalkonium chloride, Benzocaine
Label structure10 sections

Indications and uses

To treat cold sores/fever blisters.

Dosage and administration

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 hol...

Storage and handling

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • To treat cold sores/fever blisters.

Warning

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if:

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

OTC - ASK DOCTOR SECTION

Ask a doctor if:

  • You are pregnant or nursing a baby

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Isopropyl alcohol (70% v/v), water

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Principal Display Panel - 2 Vial Carton
Principal Display Panel - 2 Vial Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545787benzalkonium chloride 0.13 % / benzocaine 7.5 % Topical SolutionPSN1
1545789benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical Solution [Viroxyn]SBD1
1545787benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical SolutionSCD1
1545787benzalkonium chloride 0.13 % / benzocaine 7.5 % Topical SolutionSY1
1545789Viroxyn (benzalkonium chloride 0.13 % / benzocaine 7.5 % ) Topical SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66774-1003-22019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-32019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-42019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-52019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66774-1003-2Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-2Viroxyn Professional Use2 in 1 BLISTER PACKLIQUID21
66774-1003-3Viroxyn Professional Use3 in 1 BLISTER PACKLIQUID31
66774-1003-3Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-4Viroxyn Professional Use6 in 1 BOXLIQUID61
66774-1003-4Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-5Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-5Viroxyn Professional Use12 in 1 BLISTER PACKLIQUID121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66774-1003VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1Legacy NDC, 8 package rows20121106_a7576e67-f1df-4653-a0bf-0495ec4883b1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W71
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
BenzocaineACTIVE MOIETYU3RSY48JW51
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163021
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66774-100366774-1003-2, 66774-1003-3, 66774-1003-4, 66774-1003-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium chlorideF5UM2KM3W7ACTIB
BenzocaineU3RSY48JW5ACTIB
Isopropyl AlcoholND2M416302IACT
Water059QF0KO0RIACT

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 ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact 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 ALCOHOLND2M416302GEL / TOPICAL75 mgExact 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 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, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact 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
4fc1e4bd-01d8-4675-9e2e-a4ff884bda11a7576e67-f1df-4653-a0bf-0495ec4883b12012-11-02WarningsExact identifier
spl id: 4fc1e4bd-01d8-4675-9e2e-a4ff884bda11
spl set id: a7576e67-f1df-4653-a0bf-0495ec4883b1

Reported adverse events (FAERS/openFDA)#

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