Virasal

Manufacturer
Elorac, Inc.
Effective date
2020-01-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:31:18

Label at a glance#

ProductVirasal
Active ingredientsalicylic acid
Label structure3 sections

Label contents#

Full prescribing information#

Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle - Package Insert Text:

SPL PATIENT PACKAGE INSERT SECTION

SPL UNCLASSIFIED SECTION

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION

DESCRIPTION SECTION

Virasal is a topical preparation containing 27.5% salicylic acid in a proprietary film-forming vehicle that comprises isopropyl alcohol, butyl acetate, polyvinyl butyral, isopropyl metacresol, trimethyl pentanyl diisobutyrate, phenic acid and acrylates copolymer. The pharmacologic activity of Virasal is generally attributed to the keratolytic activity of salicylic acid which is incorporated into a polyacrylic, film-forming virucidal vehicle designed to cover the wart without the need for a bandage. The structural formula of salicylic acid is:

structure.jpg
structure.jpg

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Although the exact mode of action for salicylic acid in the treatment of warts is unknown, its activity appears to be associated with its keratolytic action, which results in mechanical removal of epidermal cells infected with wart viruses.

The virucidal complex incorporated into Virasal’s proprietary vehicle is designed to help reduce risk of reinfection at the wart site, as well as prevent viral contamination of the product under normal usage.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Virasal is indicated for the topical treatment and removal of common warts and plantar warts.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Patients with diabetes or impaired blood circulation should not use Virasal. Virasal also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.

PRECAUTIONS

GENERAL PRECAUTIONS SECTION

Virasal is for external use only. Do not permit Virasal to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes. Virasal should not be allowed to contact normal skin surrounding wart, since localized irritation may occur. Treatment should be discontinued if excessive irritation occurs. Virasal is flammable. Keep away from fire or flame. Keep bottle tightly capped when not in use.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

A localized irritant reaction may occur if Virasal is applied to the normal skin surrounding the wart. Any irritation may normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Prior to applying Virasal, soak wart in warm water for five minutes. Remove any loosened tissue by gently rubbing with a brush, wash cloth, or emery board. Dry wart site thoroughly. Using the brush applicator supplied, apply Virasal twice to entire wart surface, allowing the first application to dry before applying the second. Continue treatment once or twice a day as directed by physician. Be careful not to apply to surrounding skin.

Clinically visible improvement will normally occur during the first or second week of therapy. Maximum resolution may be expected after four to six weeks of Virasal use.

HOW SUPPLIED

HOW SUPPLIED SECTION

Virasal is supplied in 10ml amber bottles with a brush applicator (NDC 42783-312-10).

Store at controlled room temperature, 15° to 30°C (59° to 86°F).

Manufactured for:
Elorac, Inc.
Vernon Hills, IL 60061

U.S. Patent Pending

Revised 06/2011

221619

Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle - Container Label Principal Display Panel Text:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42783-312-10

Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle

Wart Remover

FOR TOPICAL USE ONLY
NOT FOR USE IN THE EYES

Rx only

1/3 fl. oz (10 mL)

ViraSal Bottle Label 26Sep2014.jpg
ViraSal Bottle Label 26Sep2014.jpg

Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle - Carton Label Principal Display Panel Text:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42783-312-10

Virasal (27.5% Salycylic Acid) Antiviral Film-Forming Vehicle

Wart Remover

FOR DERMATOLOGICAL USE ONLY
NOT FOR USE IN THE EYES

Rx only

1/3 fl. oz (10 mL)

ViraSal Carton Label 26Sep2014b.jpg
ViraSal Carton Label 26Sep2014b.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1095689salicylic acid 27.5 % Topical SolutionPSN4
1095693VIRASAL 27.5 % Topical SolutionPSN4
1095693salicylic acid 275 MG/ML Topical Solution [Virasal]SBD4
1095689salicylic acid 275 MG/ML Topical SolutionSCD4
1095689salicylic acid 27.5 % Topical SolutionSY4
1095693Virasal 27.5 % Topical SolutionSY4
1095693Virasal 275 MG/ML Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42783-312-102022-01-28C16284748780-1d6a99b39-d2f8-a426-e053-dadaa90af4c28a1c30fa-b673-4fb7-b33e-75a966da39e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-312-10Virasal1 in 1 CARTONSOLUTION14
42783-312-10Virasal10 mL in 1 BOTTLE, WITH APPLICATORSOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-312VIRASAL (SALICYLIC ACID) SOLUTION [ELORAC, INC.]4Legacy NDC, 2 package rows20200116_8a1c30fa-b673-4fb7-b33e-75a966da39e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42783-312-10ML - Milliliter42783-312f69068ea-50d5-4378-8e85-529f5957c99712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
salicylic acidACTIVE INGREDIENTO414PZ4LPZ2
salicylic acidACTIVE MOIETYO414PZ4LPZ2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42783-31242783-312-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
salicylic acidO414PZ4LPZACTIB

Source Document#

Source XML

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
d624d0ef-9062-416b-9c9d-5ba904ad8c478a1c30fa-b673-4fb7-b33e-75a966da39e92020-01-15Adverse reactionsExact identifier
spl id: d624d0ef-9062-416b-9c9d-5ba904ad8c47
spl set id: 8a1c30fa-b673-4fb7-b33e-75a966da39e9

Reported adverse events (FAERS/openFDA)#

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