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Burkhart Neutral pH

Generic: Sodium Fluoride

Verified·Apr 23, 2026
Manufacturer
Burkhart
NDC
43498-150
RxCUI
245593
Route
DENTAL
ICD-10 indication
Z29.3

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About Burkhart Neutral pH

Sodium Fluoride 1.1% Neutral is a prescription-strength fluoride gel distributed by Burkhart, used to prevent tooth decay and strengthen dental enamel. It is primarily designed for patients at high risk for cavities or tooth sensitivity. The neutral pH formulation is safe for individuals with dental restorations such as porcelain crowns, composite fillings, or bridges, as it will not etch these materials. It is typically used once daily as a brush-on gel or in a tray as part of a regular oral hygiene routine.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Burkhart Neutral pH. Official source: DailyMed (NLM) · Label effective Feb 2, 2022

Indications and usage
Indications and Usage: A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.
Dosage and administration
Dosage and Administration: Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Warnings
Warnings: Keep out of reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Read directions carefully before using.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.