Mdacne Customized Acne Treatment Benzoyl Peroxide Cream
FDA Label NDC 71804-536

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mdalgorithms Inc for the product Mdacne Customized Acne Treatment Benzoyl Peroxide (NDC 71804-536). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts:, active ingredient:, purpose, indications:, warnings:, when using this product, do not use if you, stop using and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredient:

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment

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.

Warnings:

For external use only.

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.

Do Not Use If You

  • have very sensitive skin. 
  • are sensitive to benzoyl peroxide. 

Stop Using And Ask A Doctor

is irritation becomes severe.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breastfeeding,

ask a health professional before use.

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.

Other Information:

Store in a cool, dry place below 20°C (70°F).

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.

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