PCXX ONE MINTE GEL LUSCIOUS LIME- 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 LM FRONT PANEL

PCXX ONE MINUTE LM SECONDARY PANEL

PCXX ONE MINTE GEL LUSCIOUS LIME 
fluoride treatment gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62007-015
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) .1 mg  in 1 mg
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) 0.02 mg  in 1 mg
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorLIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62007-015-161 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(62007-015)

Revised: 5/2014
Document Id: b52d0568-d6dc-4f22-bac1-43acd440f54a
Set id: 8a97d303-a061-4e5d-b963-8efb4aaaac09
Version: 1
Effective Time: 20140521
 
Ross Healthcare Inc.