Recommended Use:
A topical anticaries preparation for dental use only.
Neutragel
FDA Label NDC 61508-0370
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Germiphene Corporation for the product Neutragel (NDC 61508-0370). 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 recommended use:, otc - purpose, medicinal ingredient:, non-medicinal ingredients:, directions:, warning/caution:, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
1.1% Neutral sodium fluoride gel for topical fluoride gel treatments. Neutragel provides 0.5% fluoride ion from sodium fluoride in a neutral (pH7), unflavored, unsweetened, stabilized gel base. The special formulation is non-etching on porcelain or ceramic filled restorations. Ideal for chemotherapy and Zerostomia patients.
Medicinal Ingredient:
0.5% fluoride ion (from 1.1% sodium fluoride)
Non-Medicinal Ingredients:
Purified water, glycerin carboxymethylcellulose sodium, sodium benzoate, sodium citrate, and citric acid anhydrous.
Directions:
1. Fill Germiphene brand disposable Gel Trays. After thorough prophylaxis, air dry teeth and insert trays for four minutes. 2. Remove trays and excess gel.
Warning/Caution:
Do not eat, drink, or rinse for 30 minutes after treatment. Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
227 G (Ng 227)
450 G (Ng 450ml Lab)
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