Your browser does not support JavaScript! BORTONS MENTICOL (ETHYL ALCOHOL, MENTHOL) LIQUID [J-MARK INTERNATIONAL INC]
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BORTONS MENTICOL (ethyl alcohol, menthol) liquid
[J-Mark International Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50790-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL69.5 mL  in 100 mL
MENTHOL (MENTHOL) MENTHOL1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50790-200-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33305/06/2010
Labeler - J-Mark International Inc (853770001)
Registrant - J-Mark International Inc (853770001)
Establishment
NameAddressID/FEIBusiness Operations
J-Mark International Inc853770001manufacture

Revised: 5/2010
 
J-Mark International Inc

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