PCXX ONE MINTE GEL CREME DE MENTHE- fluoride treatment 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.

----------

PCXX ONE MINUTE MT FRONT PANEL

PCXX ONE MINUTE MT SECONDARY PANEL

PCXX ONE MINTE GEL CREME DE MENTHE 
fluoride treatment gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-006
Route of Administrationtopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION27.2 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) .03 mg  in 1 mg
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorCREME DE MENTHEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-006-161 mg in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/21/2014
Labeler - Ross Healthcare Inc. (244249012)
Registrant - Ross Healthcare Inc. (244249012)
Establishment
NameAddressID/FEIBusiness Operations
Ross Healthcare Inc.244249012manufacture(62007-006)

Revised: 5/2014
Document Id: b2a2cf43-894c-4684-8389-b643e7e6cc84
Set id: 47d28652-9ec2-4ca9-b6c7-8007b3e0963b
Version: 1
Effective Time: 20140521
 
Ross Healthcare Inc.