Label: PRO-DEN RX- sodium fluoride gel
- NDC Code(s): 59883-821-02
- Packager: DEN-MAT HOLDINGS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 4, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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OTC - ACTIVE INGREDIENT
Description:
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).
Inactive Ingredients:
Diatomite, Flavor, Glycerin, Carboxymethyl Cellulose, Phosphoric Acid,
Sodium Benzoate, Sodium Saccharin and Purified Water.
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OTC - PURPOSE
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.
Indications and Usage:
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.
Warnings: 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.
Precautions:
Limited to topical use in mouth only. DO NOT SWALLOW.
Overdosage:
Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.
Dosage and Administration:
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.
Cherry Limeade: NDC 59883-821-02
References:
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.
Rx Only
1-800-228-5595
REORDER NUMBER: 2250CLM
Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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WARNINGS SECTION
Warnings: 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.
Precautions:
Limited to topical use in mouth only. DO NOT SWALLOW.
Overdosage:
Swallowing a normal treatment dose (approx. 2 mg of fluoride) is not harmful.
- INACTIVE INGREDIENT SECTION
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INDICATIONS & USAGE SECTION
Indications and Usage:
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.
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DOSAGE & ADMINISTRATION SECTION
Dosage and Administration:
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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59883-821 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 4.3 g in 1 g Inactive Ingredients Ingredient Name Strength DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-821-02 1 in 1 CARTON 11/21/2008 1 56 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/21/2008 Labeler - DEN-MAT HOLDINGS, LLC (809857704)
