Label: PCXX ROOTBEER APF F- sodium fluoride aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 62007-060-07 - 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 November 21, 2017
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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
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INGREDIENTS AND APPEARANCE
PCXX ROOTBEER APF F
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-060 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 0.0272 g in 1 g Product Characteristics Color Score Shape Size Flavor ROOT BEER Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62007-060-07 125 g in 1 CAN; 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. (244249012)
