PCXX REMIN 0.4- 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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SECONDARY PANEL RMN

Front Panel RMG

PCXX REMIN 0.4 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION20 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.02 mg  in 1 mg
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-041-021 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/2015
Labeler - Ross Healthcare Inc. (064974821)

Revised: 3/2019
Document Id: 83d5b60e-f021-4617-e053-2a91aa0a7537
Set id: 5d489e8b-58a0-4d4a-940e-e6906256c573
Version: 2
Effective Time: 20190311
 
Ross Healthcare Inc.