Label: PRO-DEN RX- sodium fluoride rinse
- NDC Code(s): 59883-920-16, 59883-922-16
- Packager: Den-mat Holdings, Llc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 28, 2019
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- Official Label (Printer Friendly)
- Description:
- Active Ingredient:
- Inactive Ingredients:
- Clinical Pharmacology:
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Indications and Usage:
Aids in the prevention of dental caries. May be used more than once a week if recommended by your dentist. Pro-DenRx ® Rinse is ready to use, convenient and thus increases compliance.
Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental cares in adults and children. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
- Contraindications:
- Warnings:
- Precautions:
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Dosage and Administration:
Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of Pro-DenRx® 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using.
- How Supplied:
- Principal Display Panel - Bottle Label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride rinseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59883-920 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-920-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/21/2008 PRO-DEN RX
sodium fluoride rinseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59883-922 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color Score Shape Size Flavor BERRY (BERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59883-922-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2008 12/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/21/2008 12/31/2014 Labeler - Den-mat Holdings, Llc (809857704)