Mdacne Customized Acne Treatment Sulfur Cream
FDA Label NDC 71804-535

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 Sulfur (NDC 71804-535). 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:, do not use on, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredient:

Sulfur 3.0%

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.

Do Not Use On

broken skin or large areas of the skin. 

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, only use one topical acne medication at a time.
  • apply only to areas with acne.

Keep Out Of Reach Of Children.

If swallowed, get medical 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.

Other Information:

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

Inactive Ingredients:

Aqua (Deionized Water), Azelaic Acid, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice Extract, Hamamelis Viginiana (Witch Hazel), Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Niacinamide, Olea Europaea (Olive) Oil, Parfum (Fragrance), PEG-150 Distearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Steareth-2, Steareth-20, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

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