BORTONS MENTICOL- ethyl alcohol, menthol liquid

Bortons Menticol by

Drug Labeling and Warnings

Bortons Menticol by is a Otc medication manufactured, distributed, or labeled by J-Mark International Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts/Medicamento

Active Ingredients/Ingredients activo            Purpose/Proposito

Ethyl Alcohol/Alcohol Etilico 69.5%             Antiseptic/Antiseptico

Methol/Mentol 1%                                      Topical Anagesic/Anagesico topico

PURPOSE

 USES/USO  

First Aid to help reduce the risk of infection in minor cuts and scrapes/Primeros Auxillos para ayudar a reducir el riegsgo de infeccion en cortadas menores y raspones

For temporary relief of itching associated with insect bites. Para ailvio temporal de: comezon asociado con picaduras de insecto

WARNINGS

Warnings/Advertencias

For external use only. do not use in or near the eyes. In case of deep or puncture wounds consult your doctor/ Para uso externo solamente. No para uso serca de los ojos. En caso de erina profunda, consulte con un doctor

Flammable, keep away from fire or flame. Flamable, mantenga alejado del fuego or flama

Avoid contact with the eyes/Eveitar contacto con los oj

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor./Si la condicion empeora o si los sintomas persisten por mas de 7 dias o desaparecen u ocurren nuevamente en pocos dias, descontinue el uso de este producto y consulte a un doctor

Keep out of reach of children/Mantengase alejado del alcance de los ninos

If swallowed, get medical help or contact Poison Control Center right away. Si es ingerido, obtenga ayuda medica o contacte el centro de control de envenamientos de inmediato.

DOSAGE & ADMINISTRATION

DIRECTIONS/DIRECCIONES

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Adultos y ninos de 2 anos de edad en adelante: Aplica en el area afectada no mas de 3 a 4 veces diarias

Apply to skin directly or with clean gauze, cotton, or swab./Aplicar directamente a la piel o con una gasa limpia, algodon, o isopo

Children under 2 years of age: consult a doctor/Ninos menores de 2 anos de edad: consultar a un doctor.

INACTIVE INGREDIENT

FDandC Red/Rojo 40, water/ agua

INFORMATION FOR PATIENTS

For you protection, this bottle has an imprinted seal around the cap. Do not use if tamper evident seal is missing, tampered, broken or destroyed./Para su proteccion, esta botella tiene un sello impreso alrededor de la tapa. No use si el sello falta, ha sido alterado, roto o destruido

SPL UNCLASSIFIED SECTION

Distributed by/Distribuido por

J-MARK International Inc.

0819-03925

Panama

Made In/Hecho en Panama

Expiration Date/Fecha de Expiracion 12/2015

PRINCIPAL DISPLAY PANEL

Borton's Menticol

First Aid Antiseptic

Pain Relieving Liniment

Linimentoantiseptico para primeros

auxilios y aliviar el dolor

Net contents/Contenido Neto 16 fl oz (473 ml)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BORTONS MENTICOL 
ethyl alcohol, menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50790-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69.5 mL  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50790-200-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	05/06/2010

Labeler - J-Mark International Inc (853770001)

Registrant - J-Mark International Inc (853770001)

Establishment
Name	Address	ID/FEI	Business Operations
J-Mark International Inc		853770001	manufacture