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Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse drug information

SODIUM FLUORIDE
AMD Medicom · DENTAL

Product NDC: 64778-0446

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameSODIUM FLUORIDE
Labeler / manufacturerAMD Medicom
RouteDENTAL
Drug classDrug class not supplied in source label
Product NDC64778-0446
Label effective date2026-03-05

Official product label reference

Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse — AMD Medicom

This page contains 5 source sections for SODIUM FLUORIDE, dental route. Label set 1da64824-9389-4109-bea9-b91600caf023, version 8.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Indications and Directions Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations. Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL. Advise patient not to eat, drink or rinse for 30 minutes after application. Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls
Warnings and precautions
Warnings KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for use by children under 6 years of age. Do not swallow. Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF. Do not use if seal is broken.
Product description
General Information AMD Medicom Inc. DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse Mint 1.9 L / 64 fl oz NDC 64778-0446-1 NPN 80008542 Item code 10044-M
Inactive ingredient
Non-Medicinal Ingredients Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour, sodium hydroxide
Unclassified section
Contact Information Rx Only in US Made in USA for AMD Medicom Inc. 2555 Chemin de l’Aviation, Pointe-Claire, Quebec, Canada H9P 2Z2 Questions: 1-800-361-2862 www.medicom.com

Official sources and product identifiers

Substances listed: SODIUM FLUORIDE

RxNorm identifiers: 251960, 991007

Package NDC codes

64778-0446-1, 64778-0446-3

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.