VAGISIL Anti-Itch Creme Regular Strength: Package Insert and Label Information

VAGISIL ANTI-ITCH CREME REGULAR STRENGTH- benzocaine and resorcinol cream
Combe Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

VAGISIL Anti-Itch Creme Regular Strength

Drug Facts

Active ingredient

Benzocaine 5%

Purpose

External analgesic

Active ingredient

Resorcinol 2%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask doctor if

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.

If swallowed, get medical

help or contact a Poison Control Center right away.

Directions

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

Inactive ingredients

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

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)
(click image for full-size original)

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 E mpleo : 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 A dministra ción : 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 30g
(click image for full-size original)

VAGISIL ANTI-ITCH CREME REGULAR STRENGTH
benzocaine and resorcinol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-5103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 50 mg in 1 g
RESORCINOL (RESORCINOL) RESORCINOL 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
POLYOXYL 100 STEARATE
MINERAL OIL
ISOPROPYL PALMITATE
LACTITOL
ALOE VERA LEAF
ALPHA-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
CORN OIL
CHOLECALCIFEROL
LANOLIN ALCOHOLS
METHYLPARABEN
CARBOXYPOLYMETHYLENE
ISOPROPYL MYRISTATE
ISOPROPYL STEARATE
SODIUM SULFITE
TRISODIUM HEDTA
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11509-5103-1 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (11509-5103-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 01/01/2016
Labeler — Combe Incorporated (002406502)

Revised: 09/2019 Combe Incorporated

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