Dosage form: gel
Ingredients: SODIUM FLUORIDE 4.3g in 1g
Labeler: Zila Therapeutics, Inc.
NDC Code: 59883-824
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Neutral Sodium Fluoride Topical Gel – Dye Free Gel
A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use in the protection against dental caries.
Active Ingredients: Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).
Contains: 1.1% Sodium Fluoride (5000 ppm Fluoride Ion)
Inactive Ingredients: Flavor, hydroxyethyl cellulose, sucralose, purified water.
Clinical Pharmacology: Applying preparations containing high fluoride concentrations on a regular basis increases the fluoride ion levels in tooth enamel and improves tooth resistance to acid dissolution.
It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries.1-4 Pro-DenRx Brush-On Gel can be applied on a toothbrush as well as a mouthpiece tray. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.
Contraindications: Do not use in children under 6 unless recommended by a dentist.
Warnings: KEEP OUT OF REACH OF CHILDREN.Children under 6 years old: The potential for fluorosis from repeated swallowing is possible; therefore, children under 6 years old should use only if ordered by dentist and carefully supervised by parent.
Precautions: Limited to topical use in mouth only. DO NOT SWALLOW.
Overdosage: Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful.
Apply daily after usual brushing and flossing at bedtime or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water.
When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least 1 minute. Remove applicator and rinse mouth. Clean applicators with cold water.
Store at Room Temperature
How Supplied: Net Wt. 2 oz. (56 g) tube in a box.
Cool Mint: NDC 59883-824-02
1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.
2. Englander HR, et al.: JADA 83:354-358 1971.
3. Englander HR, et al.: JADA 78:783-787 1969.
4. Englander HR, et al.: JADA 75:638-644 1967.
REORDER NUMBER: 2240MTM
442245 Rev. 1 1008
Made for and Distributed in US by:
Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503
sodium fluoride gel
|Labeler - Zila Therapeutics, Inc. (883514127)|
|Zila Therapeutics, Inc.||883514127||MANUFACTURE|
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