Label: PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 0273-7001-16 - Packager: Young Dental Manufacturing Co 1, LLC.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 14, 2018
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- INDICATIONS AND USAGE:
- 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
PERFECT CHOICE
sodium fluoride and hydrofluoric acid gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-7001 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 GRAPE (Growlin' Grrrape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0273-7001-16 497 g in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/31/2006 Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)