Neutrasal® Artificial Saliva

Neutrasal®

Powder for supersaturated calcium phosphate rinse

Ingredients: (Active) Dibasic Sodium Phosphate 0.010, Monobasic Sodium Phosphate 0.010, Calcium Chloride 0.050, Sodium Chloride 0.450, Sodium Bicarbonate 0.016,           (lnactive) Silicon Dioxide 0.002

Pharmaceutical form: Neutrasal^® is a  powder containing 538 mg of ingredients in a foil sachet intended to be dissolved or dispersed in water (tap water, distilled or purified water) before administration to form a solution supersaturated with respect to both calcium and phosphate ions.

Actions: Neutrasal^®, when dissolved or dispersed in water before use, forms an electrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate and clean the oral cavity including the mucosa of the mouth, tongue and throat. Neutrasal^® facilitates chewing and speaking; loosens tough mucus and prevents mucous membranes from sticking together.

Indications for use: Neutrasal^® is indicated for dryness of the mouth or throat (hyposalivation, xerostomia); regardless of the cause and regardless of whether the conditions are temporary or permanent. Neutrasal^® is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

Special precautions for use: Avoid eating or drinking for at least 15 minutes after use.

Neutrasal^® should not be swallowed and the solution should be spit out. NeutraSal^® must be dissolved in water before being taken.

Do not use if the foil sachet is ripped or torn or shows sign of leakage or damage.

Contains sodium. (Approximately 50 mg per 30 ml dose). Patients restricted to a low sodium diet should consult their physician before use. Store at room temperature, avoid excessive heat or moisture.

KEEP OUT OF REACH OF CHILDREN.

Interaction with other medicinal products and other forms of interaction:

There are no known interactions with medicinal or other products.

If NeutraSal® is swallowed accidentally, no adverse effects are anticipated.

Stop Use and Consult Your Doctor or Dentist if:

• An allergic reaction occurs. Seek medical help right away.
• If pregnant or breast feeding, ask a health professional before use.
• Keep out of reach of children.
• In case of overdose, get medical help immediately or contact a Poison Control Center right away .

How Supplied:

NeutraSal® is supplied in individual foil-lined sachets containing 538 mg of  ingredients.

Directions for use:

• Dissolve or disperse one sachet of Neutrasal® in a clean glass of           approximately 30 ml (1 ounce) of tap water. Distilled or purified  water can also be used.
• Use immediately after the solution appears clear or nearly clear in the                  glass, or in about 15 - 30 seconds. Product can be stirred in water.
• Swish the solution in the mouth thoroughly for 1 min with 1/2 of the                           solution and spit out.
• Repeat with the remaining 1/2 of the solution and spit out.

Fore use during high dose chemotherapy or radiation treatment:

4 doses per day from the onset of the cancer treatment or as needed. Up to 10 Doses per day may be used if pain from mucositis is experienced. Use for the duration of the treatment or as instructed by physician.

Relief of dry mouth: 2 - 10 times per day or as instructed by physician or as needed.

Manufactured by:

Advanced Pharmaceutical Technology, Inc.

132 South Central Avenue

Elmsford, NY 10532

Distributor:

Ingrid Goergen Medical Imports e.K.

Kegelbahnstr. 28

54470 Bernkastel-Kues

NeutraSal® is a prescription free medical device in Germany