Label: PRO-DEN RX- sodium fluoride gel
- NDC Code(s): 59883-820-02
- 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 February 28, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- OTC - ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- OTC - PURPOSE
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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.
- OTC - KEEP OUT OF REACH OF CHILDREN
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WARNINGS
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.
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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.
Berry Fresh: NDC 59883-822-02
Cherry Limeade: NDC 59883-821-02
Cool Mint: NDC 59883-820-02
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: 2250RBM
Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503 - 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:59883-820 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 MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-820-02 1 in 1 CARTON 10/31/2008 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 10/31/2008 Labeler - DEN-MAT HOLDINGS, LLC (809857704) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 manufacture(59883-820)
