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510(k) Data Aggregation

    K Number
    K050158
    Device Name
    SINCLAIR SEBORRHEA EMULSION
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2006-10-11

    (624 days)

    Product Code
    FRO, MGQ
    Regulation Number
    N/A
    Why 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
    K042722
    Device Name
    ALOCLAIR ORAL SPRAY
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2005-01-13

    (104 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why 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
    K040950
    Device Name
    ALOCLAIR ORAL GEL
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2004-06-21

    (70 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why 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
    K024148
    Device Name
    SALINUM, ORCLAIR
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2003-09-15

    (273 days)

    Product Code
    LFD
    Regulation Number
    N/A
    Why 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
    K024367
    Device Name
    SINCLAIR WOUND AND SKIN EMULSION
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2003-07-28

    (209 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why 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
    K023046
    Device Name
    SST SALIVA SUPPORTING TABLETS
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2002-12-02

    (81 days)

    Product Code
    LED
    Regulation Number
    864.1850
    Why 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
    K023155
    Device Name
    ALOCLAIR ORAL RINSE
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2002-11-25

    (63 days)

    Product Code
    OLR, MGO
    Regulation Number
    N/A
    Why 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
    K013056
    Device Name
    GELCLAIR CONCENTRATED ORAL GEL
    Manufacturer
    SINCLAIR PHARMACEUTICALS, LTD.
    Date Cleared
    2001-12-21

    (101 days)

    Product Code
    OLR, MGQ
    Regulation Number
    N/A
    Why 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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