Mdacne Customized Acne Treatment Cream Benzoyl Peroxide 5.0%

Mdacne Customized Acne Treatment Cream Benzoyl Peroxide 5.0%
SPL v1
SPL
SPL Set ID 236e8d2e-ccd4-0a15-e063-6394a90a73e9
Route
TOPICAL
Published
Effective Date 2024-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Water Ascorbic Acid Alkyl (c12-15) Benzoate Green Tea Leaf Caprylyl Glycol Cetostearyl Alcohol Cucumber Cyclomethicone 5 Cyclomethicone 4 Dimethicone Glycerin Glycyrrhiza Glabra Hexylene Glycol Lavender Oil Magnesium Aluminum Silicate Peg-150 Distearate Phenoxyethanol Polysorbate 80 Potassium Sorbate Propylene Glycol Steareth-2 Steareth-20 Edetate Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-12

Description

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5.0%

Warnings:

For external use only.

Questions:

Contact us at [email protected]

Drug Facts:

Directions:
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times daily
  • 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 
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sun sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Indications:
  • For the treatment of acne.
  • Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.
Do Not Use If You
  • have very sensitive skin. 
  • are sensitive to benzoyl peroxide. 
Active Ingredient:

Benzoyl Peroxide 5.0%

Other Information:

Store in a cool, dry place below 20ºC (70ºF).

Package Labelling:

Inactive Ingredients:

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 150 Distearate, Phenoxyethanol, Polysorbate 80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth 20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

When Using This Product
  • skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, use only one topical acne medication at a time.
  • avoid unnecessary sun expodure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product 
  • 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.
Stop Using and Ask A Doctor

is irritation becomes severe.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get nedical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Acne Treatment

Warnings:

For external use only.

Questions:

Contact us at [email protected]

Drug Facts: (DRUG FACTS:)

Directions:
  • clean the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one to three times daily
  • 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 
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sun sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Indications:
  • For the treatment of acne.
  • Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.
Do Not Use If You (Do not use if you)
  • have very sensitive skin. 
  • are sensitive to benzoyl peroxide. 
Active Ingredient:

Benzoyl Peroxide 5.0%

Other Information: (Other information:)

Store in a cool, dry place below 20ºC (70ºF).

Package Labelling:

Inactive Ingredients:

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 150 Distearate, Phenoxyethanol, Polysorbate 80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth 20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

When Using This Product (When using this product)
  • skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, use only one topical acne medication at a time.
  • avoid unnecessary sun expodure and use a sunscreen.
  • avoid contact with eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product 
  • 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.
Stop Using and Ask A Doctor (Stop using and ask a doctor)

is irritation becomes severe.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get nedical help or contact a Poison Control Center right away.


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Raw Label Data

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