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510(k) Data Aggregation
K Number
K091718Device Name
NEUTRASAL
Manufacturer
BARTOR PHARMACAL CO., INC.
Date Cleared
2009-09-02
(83 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BARTOR PHARMACAL CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
Device Description
Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.
Neutrasal® facilitates chewing and speaking; loosens tough mucus: prevents mucous membranes from sticking together; and improves adherence of dentures.
Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.
Syloid, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.
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