Scotts Select Nephro-stat
FDA Label NDC 69638-059

11 label sections · Submitted to the FDA by Scott's Dental Supply Llc · 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 other, description, uses, warnings, directions for use, other information, inactive ingredients, caution, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

NDC# 69638-059-20

25% Aluminum Chloride

30cc

INSTRUCTIONS FOR USE

Drug Facts

Rev. A, Date: 6/30/2016

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

Description

Active IngredientPurpose
25% Aluminum ChlorideAstringent

Uses

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. Stops gingival bleeding fast. If you should inadvertently 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.

Warnings

  • Discontinue use if irritation appears.
    For topical application only.
  • Avoid eye contact.
  • Do not use in patients with a known history of hypersensitivity to aluminum chloride.
  • For professional use only.
  • Federal law restricts the product to sale or use on the order of a dentist.

Directions For Use

  • Soak a cotton tipped applicator with Nephro-Stat.
  • Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulation appear, flush it away with water.
    This will have no effect on hemostatic action.
  • Remove the impregnated cord from sulcus.
  • Flush with water and air dry until bleeding is no longer present.

Other Information

Store at 59° – 86°F (15° – 30°C).

Protect from freezing.

Inactive Ingredients

Benzyl Alcohol, Distilled Water, Potassium Chloride, Propylene Glycol

Caution

Federal (USA) law prohibits dispensing without a prescription.

Contains no epinepherine.

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StorageRead usage instructionsAllergies & Precautions

USA
Rx Only

FOR TOPICAL APPLICATION

FOR PROFESSIONAL USE ONLY

Reordering

To reorder Scott's Select Nephro-Stat please call customer sercive at 1-800-901-3368 or by visitng WWW. SCOTTSDENTAL.COM using reorder number 245-0113.

Features

  • Nephro-Stat is a buffered 25% Aluminum Chloride Solution which contains Aluminum Chloride 6-hydrate 25% in an aqueous vehicle with buffering agents.
  • Nephro-Stat is epinephrine-free to prevent cardiac reactions.
  • Nephro-Stat effectively stops minor gingival bleeding.
  • It is recommended to arrest bleeding during crown preparations, before impression taking, for minor surgery, curettage, gingivectomies, and deep scaling.
  • Nephro-Stat is easily absorbed by retraction cords.

Principal Display Panel - 30 Cc Bottle Label

NDC# 69638-059-20

Scott's
SELECT
NEPHRO-STAT
HEMOSTATIC SOLUTION
25% Aluminum Chloride

REORDER 245-0113

30cc

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

Principal Display Panel (30 cc Bottle Label)

Principal Display Panel (30 cc Bottle Label)

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