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| Product NDC Code | 68343-123 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermisa acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 308693 | ||||
| Application Number | part333D | ||||
| Labeler Name | Montani Cosmetics Inc | ||||
| 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.Active Ingredient/Ingrediente Activo Benzoyl Peroxide 5% /Peróxido de Benzoilo 5%
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.Directions/ Instrucciones ■Clean the skin thoroughly before applying this product/ limpie bien la piel antes de aplicar este producto ■cover the entire affected area with a thin layer one to three times daily/cobra toda el area infectada con una capa ligera una a tres veces por día ■because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor/debido a que sequedad excesiva de la piel puede ocurrir, empiece con una aplicación diaria y luego, gradualmente aumente a dos o tres veces por día si es necesario o indicado por un medico ■If bothersome dryness or peeling occurs, reduce application to once a day or every other day /si se le presenta una sequedad o pelado fastidioso, reduzca la aplicación a una vez por día o cada otro día if going outside, apply sunscreen after this product. ■If irritation or sensitivity develops, stop use of both products and ask a doctor/si sale afuera aplique un protector solar después de este producto. Si desarrolla una irritación o sensibilidad pare el uso de ambos productos y consulte a un medico.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients/ Ingredientes Inertes Aloe Vera Gel/Aloe Vera Gel, Aluminum Hydroxide/Hidroxido de Aluminio, Carbomer/Carbomer, Glyceryl Monostearate/Monoestearato de Glicerilo, IsopropylMyristate/Miristato de Isopropilo, Magnesium Aluminum Silicate/Silicato de Aluminio y Magnesio, Methylparaben/Metylparabeno, PEG 12/PEG 12, PropyleneGlycol/Propylenglicol, Propylparaben/Propilparabeno, Purified Water/Agua Purificada
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.Uses/Usos For the treatment of acne and to help prevent new acne blemishes / Para el tratamiento de acne y para ayudar a prevenir manchas de acné
Purpose
Information about the drug product’s indications for use.Purpose/Proposito Acne Treatment/Tratamiento para Acné
Spl product data elements
Usually a list of ingredients in a drug product.Dermisa Acne Treatment Benzoyl Peroxide POLYETHYLENE GLYCOL 600 ALOE VERA LEAF ALUMINUM HYDROXIDE CARBOMER 940 GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE MAGNESIUM ALUMINUM SILICATE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER BENZOYL PEROXIDE BENZOYL PEROXIDE
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.Package Label Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information/ Otra Información ■Keep cap closed tightly / mantenga la tapa bien cerrada *Store at room temperature/mantenga producto a temperatura de ambiente
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.Do not use if you ■have very sensitive skin or are sensitive to Benzoyl Peroxide/ No utilizar si usted ■tiene pielsensible o si es sensible a Peróxido de Benzoilo
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.Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately/ Mantenga fuera del alcance de los niños. Si lo injiere inmediatamente busque atención médica o contacte a un Centro de Control de Envenenamiento
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■irritation becomes severe/ Pare el uso y consulte con un medico ■si la irritación se hace más severa
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product /Al utilizar este producto ■avoid unnecessary sun exposure and always use a sunscreen/evite exposición innecesaria al sol y use un bloqueador solar ■avoid contact with eyes, lips and mouth/evite contacto con los ojos, labios y boca ■avoid contact with hair and dyed fabrics which may be bleached by this product/evite el contacto con el pelo y materiales con tintes que pueden ser decolorados por este producto ■skin irritation may occur characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration/irritación de la piel puede ocurrir caracterizado por quemazón, enrojecimiento, picazón, peladura o posiblemente hinchazón. La irritación se puede reducer disminuyendo la frecuencia de uso del producto o usándolo en menor concentración.
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.Warnings/Advertencias *For external use only / Solamente para uso externo
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