FDA Label for Mdacne Customized Acne Treatment Sulfur

View Indications, Usage & Precautions

Mdacne Customized Acne Treatment Sulfur Product Label

The following document was submitted to the FDA by the labeler of this product Mdalgorithms Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Questions:



Contact us at [email protected]


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