Dermisa Acne Treatment

Manufacturer
Montani Cosmetics Inc | Derma Care Research Labs, LLC
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:46

Label at a glance#

ProductDermisa Acne Treatment
Active ingredientBENZOYL PEROXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient/Ingrediente Activo

Benzoyl Peroxide 5% /Peróxido de Benzoilo 5%

OTC - PURPOSE SECTION

Purpose/Proposito

Acne Treatment/Tratamiento para Acné

INDICATIONS & USAGE SECTION

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 SECTION

Warnings/Advertencias*For external use only / Solamente para uso externo

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Other Information/ Otra Información­

■Keep cap closed tightly / mantenga la tapa bien cerrada *Store at room temperature/mantenga producto a temperatura de ambiente

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308693benzoyl peroxide 5 % Topical CreamPSN2
308693benzoyl peroxide 50 MG/ML Topical CreamSCD2
308693benzoyl peroxide 5 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68343-123-01Dermisa Acne Treatment28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68343-123DERMISA ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [MONTANI COSMETICS INC]2Current NDC, Legacy NDC, 1 package rows20241217_d61a6354-8194-da19-e053-2995a90a7e22.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68343-12368343-123-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermisa Acne TreatmentBENZOYL PEROXIDEMontani Cosmetics Incd61a6354-8194-da19-e053-2995a90a7e222024-12-15WarningsExact identifier
ndc (package): 68343-123-01
ndc (product): 68343-123
ndc11 (package): 68343012301
spl id: 295765fa-6050-0b18-e063-6394a90a8c49
spl set id: d61a6354-8194-da19-e053-2995a90a7e22

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.