PCXX HOME TREATMENT 1.1- 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 HOME TREATMENT 1.1 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg  in 1 mg
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-035-0260 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/201503/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/201503/29/2019
Labeler - Ross Healthcare Inc. (064974821)

Revised: 3/2019
Document Id: 853eee29-6f80-59d4-e053-2991aa0aa611
Set id: 68f8beeb-94ff-48cc-844c-2af36e2a2a7c
Version: 3
Effective Time: 20190329
 
Ross Healthcare Inc.