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| Product NDC Code | 0219-0203 | ||||
|---|---|---|---|---|---|
| Drug Name | Humphreys bendito alcoholado |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1370957 | ||||
| Application Number | part348 | ||||
| Labeler Name | Humphreys Pharmacal, Incorporated | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Ingrediente activo / Active ingredients Mentol / Menthol 1.25%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Instrucciones / Directions Adultos y niños de 2 años en adelante: Aplique sobre la zona afectada no más de 3 ó 4 veces al dia. Niños menores de 2 años en edad: consulte a un médico. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredientes inactivos / Inactive ingredients camphor, eucalyptol, FDC blue #1, FDC yellow #5, isopropyl alcohol, methyl salicylate, and purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Usos / Uses Para un alivio temporal de dolores musculares y dolores en las articulaciones asociados con: artritis moretones esguinces tensión achaques de espalda For the temporary relief of minor aches and pains of muscles and joints associated with: arthritis bruises sprains strains simple backache
Purpose
Information about the drug product’s indications for use.Propósito / Purpose Analgesia Tópica / Topical Anaglesic
Spl product data elements
Usually a list of ingredients in a drug product.Humphreys Bendito Alcoholado menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CAMPHOR (SYNTHETIC) EUCALYPTOL FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ISOPROPYL ALCOHOL METHYL SALICYLATE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.The labels shown below represent a sample of that currently in use. Additional packaging may also be available. HUMPHREYS BENDITO ALCOHOLADO Analgesia Tópica / Topical Anaglesic REFRESCA - CALMA - PENETRA Bendito Label FB
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.No use este producto si su piel es sensible al aceite de menta-verde (salicilato de metilo). No aplique a heridas ni a la piel maltratada. No ponga un vendaje muy apretado. Do not use if skin is sensitive to oil of wintergreen (methylsalicylate). Do not apply to wounds or damaged skin. Do not bandage tightly.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Mantenga fuera del alcance de niños. Si se ingiere, consiga asistencia médica o llame al Centro de Control de Venenos inmediatamente. Keep out of the reach of children. If swallowed,get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Distribuido por / Dist. by: Humphreys Pharmacal, Inc. East Hampton, CT 06424 Made in USA www.humphreysusa.com
Storage and handling
Information about safe storage and handling of the drug product.Otra información / Other information Almacene debajo de 30C / Store below 86F
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.Inflamable. Mantenga alejado del fuego, chispas y superficies calientes. Flammable keep away from fire, sparks and heated surfaces.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Advertencias / Warnings Para uso externo solamente. Evite el contacto con los ojos o las membranas mucosas. Si la condición empeora o los síntomas persisten por más de 7 dias, o si se aliviany retoman días después, interrumpa el uso del producto y consulte a un médico. For external use only. Avoid contact with eyes or mucous membranes. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API