Pro-Den Rx by Zila Therapeutics, Inc.
Medically reviewed on January 18, 2018
Dosage form: gel
Ingredients: SODIUM FLUORIDE 4.3g in 1g
Labeler: Zila Therapeutics, Inc.
NDC Code: 59883-820
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.
A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use to aid in the protection against dental caries in adults and pediatric patients.
Neutral Sodium Fluoride 1.1% w/w (5000 ppm F).
Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid, Sodium Benzoate, Sodium Saccharin and 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 ProDenRx Brush-On Gel may be applied using a toothbrush. 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.
PLEASE 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.
Limited to topical use in mouth only. DO NOT SWALLOW.
Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.
Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel.
Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use.
Store at Room Temperature
How Supplied: Net Wt. 2 oz. (56 g) tube in a box.
Berry Fresh: NDC 59883-822-02
Cherry Limeade: NDC 59883-821-02
Cool Mint: NDC 59883-820-02
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: 2250RBM
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)|
|Medical Product Laboratories||002290302||MANUFACTURE|