Label: PRO-DEN RX- sodium fluoride rinse
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Contains inactivated NDC Code(s)
NDC Code(s): 59883-912-64 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Dosage and Administration
Dispense ½ oz. (approx. 1 pump) of Pro-DenRx 2.0% Neutral Sodium Fluoride Solution into the provided mixing cup. Instruct patient to rinse vigorously for 30 seconds with ½ oz. of the solution around and between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional ½ oz. of solution. Pro-DenRx 2.0% Neutral Sodium Fluoride Solution may also be applied full strength, with cotton pledgets, to teeth isolated with cotton rolls.
- Recommended Frequency
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Caution
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Overdosage
Accidental ingestion of large amounts of fluoride can cause: nausea, vomiting, abdominal pain, diarrhea, stupor and/or weakness (usually within 30 minutes). These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (less than 23 mg fluoride/lb body weight) has been ingested, give calcium (milk) orally to relieve symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (more than 23 mg fluoride/lb body weight) has been ingested, induce vomiting, give calcium (i.e., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight) induce vomiting, transport and admit immediately to a hospital facility.
- Ingredients
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How Supplied/Storage and Handling
2.0% Neutral Sodium Fluoride (0.9% Fluoride Ion) oral solution supplied in a plastic bottle with child-resistant closure containing 64 fl. oz. (1.89 L). Store at room temperature. Protect from freezing. Do not store in direct sunlight.
Rx Only
Revised: 01/2015
1-800-433-6628
Reorder Number: 2037RBDT
Manufactured for
Den-Mat Holdings, LLC
1017 W. Central Ave.
Lompoc, CA 93436
©2015 Den-Mat Holdings, LLC. All rights reserved. 001394900 06/15SN
- Principal Display Panel - 64 fl. oz. Bottle Label
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INGREDIENTS AND APPEARANCE
PRO-DEN RX
sodium fluoride rinseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59883-912 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) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM PHOSPHATE (UNII: SE337SVY37) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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:59883-912-64 1890 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 Labeler - Den-mat Holdings, Llc (809857704)
