PCXX ONE MINUTE COOL PEPPERMINT- 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 ONE MINUTE PT FRONT PANEL

PCXX ONE MINUTE PT SECONDARY PANEL

PCXX ONE MINUTE COOL PEPPERMINT 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-054
Route of Administrationtopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) .001 mg  in 1 mL
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-054-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/03/2015
Labeler - Ross Healthcare Inc. (244249012)
Registrant - Ross Healthcare Inc. (244249012)
Establishment
NameAddressID/FEIBusiness Operations
Ross Healthcare Inc.244249012manufacture(62007-054)

Revised: 2/2015
Document Id: 90e7dab2-96ab-4cc2-a2f7-89bf11fcd96c
Set id: 5bcb9e45-82b4-47b6-804e-9b301df94849
Version: 1
Effective Time: 20150203
 
Ross Healthcare Inc.