PCXX APF RNS GRAPE- 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 APF RNS GRAPE

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 APF RNS GRAPE 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-313
Route of AdministrationTOPICAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.2 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-313-641900 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/24/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/24/201711/24/2017
Labeler - Ross Healthcare Inc. (244249012)

Revised: 11/2017
 
Ross Healthcare Inc.