Label: ALPHA-PRO- sodium fluoride and hydrofluoric acid gel
- NDC Code(s): 55346-0942-1
- Packager: Dental Technologies, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated December 11, 2017
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- Indications and Usage:
- Contraindications:
- Warning:
- Precautions:
- Adverse Reactions:
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Dosage and Administration:
After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.
- How Supplied:
- Active Ingredients:
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INGREDIENTS AND APPEARANCE
ALPHA-PRO
sodium fluoride and hydrofluoric acid gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55346-0942 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.9 mg in 1 g HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.4 mg in 1 g Product Characteristics Color Score Shape Size Flavor STRAWBERRY (Strawberry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-0942-1 497 g in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2013 Labeler - Dental Technologies, Inc. (148312838)