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Found 8 results
510(k) Data Aggregation
K Number
K050158Device Name
SINCLAIR SEBORRHEA EMULSION
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2006-10-11
(624 days)
Product Code
FRO, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.
Device Description
Sinclair Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over- the-counter (OTC) use.
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K Number
K042722Device Name
ALOCLAIR ORAL SPRAY
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2005-01-13
(104 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALOCLAIR™ ORAL SPRAY is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further imitation.
ALOCLAIR™ ORAL SPRAY is indicated for all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers caused by braces and ill fitting dentures and diffused aphthous ulcers.
Device Description
ALOCLAIR™ ORAL SPRAY is a viscous spray formulation, which is presented for over-thecounter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
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K Number
K040950Device Name
ALOCLAIR ORAL GEL
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2004-06-21
(70 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SINCLAIR ALOCLAIR™ ORAL GEL is indicated for pain relief in all types of mouth lesions, aphthous stomatitis, aphthous ulcers, minor lesions, chafing and traumatic ulcers and abrasions caused by braces and ill fitting dentures and diffused aphthous ulcers. Aloclair Gel forms a protective film that covers lesions to provide rapid pain relief, and avoid further irritation.
Device Description
ALOCLAIR™ ORAL GEL is a viscous gel formulation, which is presented for over-the-counter use premixed in various sizes. This combination of substances, when rinsed around the mouth, forms a protective layer over the oral mucosa.
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K Number
K024148Device Name
SALINUM, ORCLAIR
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2003-09-15
(273 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.
Over the counter Labeling stipulates that ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
Device Description
SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.
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K Number
K024367Device Name
SINCLAIR WOUND AND SKIN EMULSION
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2003-07-28
(209 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.
Device Description
Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (OTC) use.
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K Number
K023046Device Name
SST SALIVA SUPPORTING TABLETS
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2002-12-02
(81 days)
Product Code
LED
Regulation Number
864.1850Why did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.
Device Description
SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.
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K Number
K023155Device Name
ALOCLAIR ORAL RINSE
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2002-11-25
(63 days)
Product Code
OLR, MGO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SINCLAIR ALOCLAIR™ ORAL RINSE Aloclair Oral Rinse with Aloe Vera extract, adheres to the mucosal surface and provides rapid pain relief from aphthous ulcers, canker sores, and minor oral lesions, including ulcers caused by braces and ill fitting dentures.
Device Description
ALOCLAIR™ ORAL RINSE is a viscous gel formulation, which is presented for over-thecounter use premixed in containers of various sizes with plastic measuring cup. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
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K Number
K013056Device Name
GELCLAIR CONCENTRATED ORAL GEL
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2001-12-21
(101 days)
Product Code
OLR, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sinclair Gelclair® CONCENTRATED ORAL GEL, has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated also for diffuse aphthous ulcers.
Device Description
Sinclair Pharmaceuticals, Ltd. Gelclair® CONCENTRATED ORAL GEL is a viscous gel formulation, which is presented in a sachet of 15ml for mixing with 40ml of water. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
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