Label: PCXX VANILLA ORANGE NEUTRAL GL- sodium fluoride gel
- NDC Code(s): 62007-823-16
- Packager: Ross Healthcare Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated February 23, 2019
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DOSAGE & ADMINISTRATION
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minute
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PCXX VANILLA ORANGE NEUTRAL GL
sodium fluoride gel
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-823 Route of Administration DENTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 20 mg in 1 mL Product Characteristics Color orange Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-823-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/22/2019 Labeler - Ross Healthcare Inc. (064974821)