PCXX ANTICARIES NO FLAVOR NE G- 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 ANTICARIES NO FLAVOR NE G

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 ANTICARIES NO FLAVOR NE G 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-030
Route of AdministrationDENTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11.1 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-030-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201702/12/2018
Labeler - Ross Healthcare Inc. (064974821)

Revised: 1/2023
Document Id: f38561ca-6f48-7a36-e053-2a95a90a38f6
Set id: 5f4fd5bf-445e-d0fd-e053-2a91aa0ac8e4
Version: 5
Effective Time: 20230130
 
Ross Healthcare Inc.