Label: BORTONS MENTICOL- ethyl alcohol, menthol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50790-200-16 - Packager: J-Mark International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 14, 2010
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- ACTIVE INGREDIENT
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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
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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.
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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
- INFORMATION FOR PATIENTS
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INGREDIENTS AND APPEARANCE
BORTONS MENTICOL
ethyl alcohol, menthol liquidProduct 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