Bortons Menticol
FDA Label NDC 50790-200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J-mark International Inc for the product Bortons Menticol (NDC 50790-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, information for patients, other, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Warnings

→ Dosage & Administration

→ Inactive Ingredient

→ Information For Patients

→ Other

→ Package Label.principal Display Panel

Otc - 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

Otc - 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