PCXX VANILLA ORANGE NEUTRAL GL- sodium fluoride gel 
Ross Healthcare Inc.

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.

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PCXX VANILLA ORANGE NEUTRAL GEL

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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PCXX VANILLA ORANGE NEUTRAL GL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-823
Route of AdministrationDENTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 mL
Product Characteristics
ColororangeScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-823-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/22/2019
Labeler - Ross Healthcare Inc. (064974821)

Revised: 1/2024
Document Id: 104703f6-2bee-b92b-e063-6294a90aa658
Set id: 82978289-4943-83b1-e053-2991aa0a6365
Version: 4
Effective Time: 20240131
 
Ross Healthcare Inc.