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  5. Label Information: Therapeutic Sulfur Mask

FDA Label for Therapeutic Sulfur Mask

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENT
    10. OTC - PURPOSE
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Therapeutic Sulfur Mask Product Label

The following document was submitted to the FDA by the labeler of this product University Medical Pharmaceuticals Corp. 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.

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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