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Sodium Fluoride 1.1%

Verified·Apr 23, 2026
NDC
71085-074
ICD-10 indication
K02.9

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About Sodium Fluoride 1.1%

What is this medication? Sodium fluoride 1.1% is a prescription-strength topical fluoride treatment primarily used to prevent dental cavities and tooth decay. This medication works by increasing the mineral content of the tooth enamel, making the surface harder and more resistant to the corrosive acids produced by plaque bacteria and sugary foods. By promoting remineralization, it can help strengthen teeth and may even repair the earliest stages of decay before a permanent cavity develops. Dentists often prescribe this medication for individuals who are at an increased risk for dental problems caused by factors such as dry mouth, orthodontic appliances, or a high frequency of previous cavities. It is commonly provided as a gel or a concentrated toothpaste and is usually applied once daily at bedtime after normal brushing and flossing. For the best results, users should avoid eating, drinking, or rinsing their mouths for at least thirty minutes after application so the fluoride has enough time to be absorbed by the teeth.

Copay & patient assistance

  • Patient Copay Amount: Not Publicly Available
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Not Publicly Available
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for Sodium Fluoride 1.1%. Official source: DailyMed (NLM) · Label effective Jan 21, 2025

Indications and usage
Uses This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
Dosage and administration
Directions Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and Children 6 Years of Age and Older : Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Dosage form and Strengths : Dental gel containing 1.1% sodium fluoride.
Warnings
Warning Contraindications : Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician. Warnings and Precautions: Do no swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician. Adverse reactions: To report suspected Adverse reactions , To report suspected adverse reactions, contact IPG Pharmaceuticals at (888) 711-7116 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

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

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Prior authorization & coverage

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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.