THERAPEUTIC SULFUR MASK- sulfur cream

Therapeutic Sulfur Mask by

Drug Labeling and Warnings

Therapeutic Sulfur Mask by is a Otc medication manufactured, distributed, or labeled by University Medical Pharmaceuticals Corp, Universal Packaging Systems, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                                                     Purpose
Sulfur 3.5%...................................................................................................................................Acne Treatment

INDICATIONS & USAGE

Use for the treatment of acne

WARNINGS

Warnings For external use only

DO NOT USE

Do not use

• If you have a known allergy to salicylic acid or aspirin.
  

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.
  

STOP USE

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

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

Directions
Gently 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 Ingredients
Acacia 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.

PURPOSE

Purpose: Acne Treatment

PRINCIPAL DISPLAY PANEL

AcneFree Clear Skin Treatments

INGREDIENTS AND APPEARANCE

THERAPEUTIC SULFUR MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50544-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	35 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
kaolin (UNII: 24H4NWX5CO)
bentonite (UNII: A3N5ZCN45C)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
titanium dioxide (UNII: 15FIX9V2JP)
ACACIA (UNII: 5C5403N26O)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
ethylhexylglycerin (UNII: 147D247K3P)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
menthyl lactate (UNII: 2BF9E65L7I)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
COPPER GLUCONATE (UNII: RV823G6G67)
butylene glycol (UNII: 3XUS85K0RA)
mannitol (UNII: 3OWL53L36A)
EDETATE SODIUM (UNII: MP1J8420LU)
magnesium aspartate (UNII: R17X820ROL)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50544-004-91	1 in 1 CARTON
1	NDC: 50544-004-02	48 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/06/2011

Labeler - University Medical Pharmaceuticals Corp (809706252)

Registrant - University Medical Pharmaceuticals Corp (809706252)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, INC		177711082	manufacture