Label: DERMISA CLEAR SKIN- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68343-002-28 - Packager: Montani Cosmetics Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 19, 2019
If you are a consumer or patient please visit this version.
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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 CLEAR SKIN
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68343-002 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ALGELDRATE (UNII: 03J11K103C) 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:68343-002-28 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 final part333D 02/28/2013 Labeler - Montani Cosmetics Inc (124852331)