Label: PCXX PINA COLADA APF G- sodium fluoride gel
- NDC Code(s): 62007-008-16
- Packager: Ross Healthcare Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 9, 2024
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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
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INGREDIENTS AND APPEARANCE
PCXX PINA COLADA APF G
sodium fluoride gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-008 Route of Administration TOPICAL, DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 27.2 mg in 1 mL Product Characteristics Color yellow Score Shape Size Flavor PINEAPPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-008-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/21/2017 Labeler - Ross Healthcare Inc. (064974821)
