OTC - ACTIVE INGREDIENT SECTION
Active Ingredient/Ingrediente Activo
Benzoyl Peroxide 5% /Peróxido de Benzoilo 5%
Active Ingredient/Ingrediente Activo
Benzoyl Peroxide 5% /Peróxido de Benzoilo 5%
Purpose/Proposito
Acne Treatment/Tratamiento para Acné
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
Warnings/Advertencias*For external use only / Solamente para uso externo
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
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.
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
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
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.
Other Information/ Otra Información
■Keep cap closed tightly / mantenga la tapa bien cerrada *Store at room temperature/mantenga producto a temperatura de ambiente
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
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| b382b4e1-6b48-45f6-bffc-e61b00b0ce19 | Product name | 3 | 20250317 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 32012d5c-25ac-49c7-9d4c-1313177fff7c | Product name | 1 | 20230112 |
| 13e7e7e3-e885-4c79-af6d-dad1aedbb06e | Product name | 1 | 20220128 |
| 4a7d44fe-774d-404b-aad0-8a90fe78375a | Product name | 4 | 20211025 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b | Product name | 3 | 20200203 |
| ee5c6de5-d9cd-454f-b250-7b19e5cf2992 | Product name | 4 | 20190619 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68343-123-01 | Dermisa Acne Treatment | 28 g in 1 TUBE | CREAM | 28 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68343-123 | 68343-123-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| ALUMINUM HYDROXIDE | 5QB0T2IUN0 | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| BENZOYL PEROXIDE | W9WZN9A0GM | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dermisa Acne Treatment | BENZOYL PEROXIDE | Montani Cosmetics Inc | d61a6354-8194-da19-e053-2995a90a7e22 | 2024-12-15 | Warnings | 68343-123-01 68343-123 68343012301 295765fa-6050-0b18-e063-6394a90a8c49 d61a6354-8194-da19-e053-2995a90a7e22 |
Adverse event summaries are temporarily unavailable. Other product information remains available.