PCXX ONE MINTE GEL VANILLA ORANGE- 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.

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PCXX ONE MINUTE VO FRONT PANEL

PCXX ONE MINUTE VO SECONDARY PANEL

PCXX ONE MINTE GEL VANILLA ORANGE 
fluoride treatment gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-011
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 RED NO. 40 (UNII: WZB9127XOA) .01 mg  in 1 mg
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .02 mg  in 1 mg
Product Characteristics
ColororangeScore    
ShapeSize
FlavorVANILLA, ORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-011-161 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(62007-011)

Revised: 5/2014
Document Id: 077f5f48-e70c-4e83-ac05-59c35808dd4a
Set id: e3d94ae0-0dee-49fb-b4f5-7e590e2e0500
Version: 1
Effective Time: 20140521
 
Ross Healthcare Inc.