VAGISIL Anti-Itch Creme Regular Strength

Manufacturer
Combe Incorporated
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:43

Label at a glance#

ProductVAGISIL Anti-Itch Creme Regular Strength
Active ingredientBENZOCAINE, RESORCINOL
Label structure10 sections

Dosage and administration

adults and children 12 years and older           apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. children under 12 years consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

VAGISIL Anti-Itch Creme Regular Strength

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Resorcinol 2%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Do not apply over large areas of the body

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 12
years and older          

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.
children under 12 yearsconsult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mineral Oil, Isopropyl Palmitate, Lactitol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vagisil
Regular strength Anti Itch Crème
Net Wt. 1 Oz (28 g)      

PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g)PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g)

MEXICO

Benzal

Crema Vagisil

Fórmula: Cada 100g contiene: Benzocaina 5g, Resorcinol 2g, Excipiente cbp 100

Auxiliar en el alivio al contacto de la comezón femenina, ayuando a prevenir una mayor irritación.

Benzal Crema Vagisil auxiliar en aliviar al contacto la comezón, ardor, irritaciones y molestias menores del área externa que rodea la vagina. Contiene un anestésico que actúa para calmar la comezón, el ardor y la irritación leve.

Indicaciones: Auxiliar en el tratamiento de comezón, ardor e irritación leve.

Modo de Empleo: Únicamente para USO EXTERNO

Evite el contacto con los ojos. No se aplique en grandes áreas del cuerpo. Si las molestias persisten por más de 3 días o desaparecen y vuelven a aparecer en pocos días, o la condición empeora, suspenda su uso y consulte a su médico. En caso de ingestión accidental, busque ayuda médica inmediamente.

Vía de Administración: Tópica. Unicamente para USO EXTERNO VAGINAL. No se deje al alcance de los niños. Consérvese del tubo bien tapado. Consérvese a no más de 30°C.

Dosis: Adultos y niñas mayores de 2 años. Aplique una capa en el área afectada no más de 3 ó 4 veces al día.

Uso en Embarazo y Lactancia: No se use durante el embarazo o lactancia.

Uso Pediátrico: No se use en niñas menores de 2 años,

Contraindicaciones: Infecciones vaginales graves. Infecciones vaginales repetidas. Hipersensibilidad a los componentes de la fórmula. Si persisten las molestias por más 3 días, los síntomas no mejoran o empeoran, consulte a su médico.

Reporte las sospechas de reacción adversa a correo: farmacovigilancia@cofepris.gob.mx

PRINCIPAL DISPLAY PANEL

Benzal Crema Vagisil

Benzocaína / Resorcinol Crema 5%, 2%

Con anestésico

Calma la comezón

Caja con tubo con 30g

PRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30gPRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
243587benzocaine 5 % / resorcinol 2 % Vaginal CreamPSN4
849742Vagisil Original Strength 5 % / 2 % Vaginal CreamPSN4
849742benzocaine 50 MG/ML / resorcinol 20 MG/ML Vaginal Cream [Vagisil Original Formula]SBD4
243587benzocaine 50 MG/ML / resorcinol 20 MG/ML Vaginal CreamSCD4
849742Benzal Vagisil Creme Regular Strength (benzocaine 5 % / resorcinol 2 % ) Vaginal CreamSY4
243587benzocaine 5 % / resorcinol 2 % Vaginal CreamSY4
849742Vagisil Original Strength (benzocaine 5 % / resorcinol 2 % ) Vaginal CreamSY4
849742Vagisil, Original Strength, Anti-Itch Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ee8a2ab-68f9-45f5-8e16-b382e1af7d34Product name120200618
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11509-5103-1VAGISIL Anti-Itch Creme Regular Strength28 g in 1 TUBECREAM284
11509-5103-1VAGISIL Anti-Itch Creme Regular Strength1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11509-5103VAGISIL ANTI-ITCH CREME REGULAR STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [COMBE INCORPORATED]4Current NDC, Legacy NDC, 2 package rows20241211_dd303ff8-0deb-4292-bfd8-5bda91f86d51.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11509-5103-1GM - Gram11509-510336c64803-4748-45e9-9b32-08c97b1f373212022-06-06

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11509-510311509-5103-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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
VAGISIL Anti-Itch Creme Regular StrengthBENZOCAINE AND RESORCINOLCombe Incorporateddd303ff8-0deb-4292-bfd8-5bda91f86d512024-12-12WarningsExact identifier
ndc (package): 11509-5103-1
ndc (product): 11509-5103
ndc11 (package): 11509510301
spl id: c557751a-53ba-467c-8bf8-2ef3c03c07b7
spl set id: dd303ff8-0deb-4292-bfd8-5bda91f86d51

Reported adverse events (FAERS/openFDA)#

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