Label: DERMISA ACNE TREATMENT- benzoyl peroxide cream
- NDC Code(s): 68343-123-01
- Packager: Montani Cosmetics Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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.
- SPL UNCLASSIFIED SECTION
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INACTIVE INGREDIENT
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
- Package Label
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INGREDIENTS AND APPEARANCE
DERMISA ACNE TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68343-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68343-123-01 28 g in 1 TUBE; Type 0: Not a Combination Product 02/28/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 02/28/2013 Labeler - Montani Cosmetics Inc (124852331) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(68343-123)