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Name:Bortons Menticol
Manufacturer:J-mark International Inc
Category:Over-the-counter (OTC) Marketed Drugs


Borton's Menticol

BORTONS MENTICOL  - alcohol and menthol liquid 
J-Mark International Inc

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.

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Borton's Menticol

Drug Facts/Medicamento

Active Ingredients/Ingredients activo            Purpose/Proposito

Ethyl Alcohol/Alcohol Etilico 69.5%             Antiseptic/Antiseptico

Methol/Mentol 1%                                      Topical Anagesic/Anagesico topico


 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/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.

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.

FDandC Red/Rojo 40, water/ agua

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

Distributed by/Distribuido por

J-MARK International Inc.

0819-03925

Panama


Made In/Hecho en Panama

Expiration Date/Fecha de Expiracion 12/2015


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)

frontlabel

backlabel


BORTONS MENTICOL 
ethyl alcohol, menthol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50790-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 69.5 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL 1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50790-200-16 473 mL in 1 BOTTLE None

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 Operations
J-Mark International Inc 853770001 manufacture

Revised: 05/2010 J-Mark International Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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