Label: PRO-DEN RX- sodium fluoride gel
- NDC Code(s): 59883-824-02
- 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 Ingredients:
- Inactive Ingredients:
- Clinical Pharmacology:
- Indications and Usage:
- Contraindications:
- Warnings:
- Precautions:
- Overdosage:
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Dosage and Administration:
Apply daily at bedtime, in place of your regular toothpaste 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 two minutes. Spit out gel. Adults: Wait 30 minutes before rinsing mouth. Children under 12: Rinse mouth thoroughly immediately after use.
When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least one minute. Remove applicator and rinse mouth. Clean applicator with cold water.
- How Supplied:
- Principal Display Panel - Carton Label
- Principal Display Panel - Tube Label
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INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59883-824 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.3 g in 1 g Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PHOSPHORIC ACID (UNII: E4GA8884NN) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:59883-824-02 1 in 1 CARTON 01/20/2009 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 unapproved drug other 01/20/2009 Labeler - Den-mat Holdings, Llc (809857704)