Description:
NEPHRO-stat is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with NEPHRO-stat solution.
Scotts Select Nephro-stat
FDA Label NDC 69638-059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scott's Dental Supply Llc for the product Scotts Select Nephro-stat (NDC 69638-059). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description:, precautions:, benefits:, directions:, contraindications:, caution:, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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Precautions:
Discontinue use if irritation appears. For topical application only. Avoid eye contact.
Benefits:
NEPHRO-stat stops gingival bleeding fast. If you should inadvertantly damage the gingival margin during tooth preparation or while placing a strip, a band or a cervical matrix, moisten the area with NEPHRO-stat which will control and stop bleeding quickly. NEPHRO-stat contains no epinephrine. The use of vasoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided. A plain gingival retraction cord can be dipped in NEPHRO-stat solution and then placed into the gingival sulcus for its hemostatic action.
Directions:
Soak a cotton tipped applicator with NEPHRO-stat. Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulum appear, flush it away with water. This will have no effect on hemostatic action. Remove the impregnated cord from sulcus. Flush with water and dry with air. If hemostasis is not achieved, repeat application, rinse with water and air dry until bleeding is no longer present.
Contraindications:
Do not use in patients with a known history of hypersensitivity to aluminum chloride.
Caution:
Keep out of reach of children.
FOR PROFESSIONAL USE ONLY.
Package Label.Principal Display Panel
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