Therapeutic Sulfur Mask
FDA Label NDC 50544-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by University Medical Pharmaceuticals Corp for the product Therapeutic Sulfur Mask (NDC 50544-004). 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 otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                                                                                     PurposeSulfur 3.5%...................................................................................................................................Acne Treatment

Indications & Usage

Use for the treatment of acne

Warnings

Warnings For external use only

Otc - Do Not Use

Do not use
  • If you have a known allergy to salicylic acid or aspirin.

Otc - When Using

When using this product
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Avoid contact with lips and mouth. Do not get into eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

Otc - Stop Use

Stop use and consult a doctor if excessive skin irritation develops or increases, discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DirectionsGently massage into clean wet skin for two to three minutes until mask turns light blue for maximum absorption. Leave on for an additional 10 minutes, until dry. Rinse off with warm water and pat dry. You may experience a tightening and cooling effect. Some individuals may find the cooling feeling too strong - simply rinse off the mask immediately if uncomfortable. Use 2-3 times per week, or as desired. Avoid eye and lip areas. Avoid unnecessary sun exposure and use a sunscreen.

Inactive Ingredient

Inactive IngredientsAcacia Senegal Gum, Bentonite, Butylene Glycol, Cellulose, Copper Gluconate, Ethylhexylglycerin, Hydroxypropyl Methylcellulose, Kaolin, Magnesium Aluminum Silicate, Magnesium Aspartate, Magnesium Stearate, Mannitol, Menthyl Lactate, Methylisothiazolinone, Phenoxyethanol, Soidum Ascobyl Phosphate, Sodium Cocoyl Isethionate, Spiraea Ulmaria Flower Extract, Tetrasodium EDTA, Titanium Dioxide, Ultramarines (CI 77007), Water/Aqua/Eau, Zinc PCA.

Otc - Purpose

Purpose: Acne Treatment

Package Label.Principal Display Panel

AcneFree Clear Skin Treatments

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