PCXX ONE MINUTE COOL PEPPERMINT

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.

PCXX ONE MINUTE PT FRONT PANEL

PCXX ONE MINUTE PT SECONDARY PANEL

PCXX ONE MINUTE COOL PEPPERMINT
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-054
Route of Administration topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION .02 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 .001 mg in 1 mL
Product Characteristics
Color blue Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62007-054-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/03/2015
Labeler — Ross Healthcare Inc. (244249012)
Registrant — Ross Healthcare Inc. (244249012)
Establishment
Name Address ID/FEI Operations
Ross Healthcare Inc. 244249012 manufacture (62007-054)

Revised: 02/2015 Ross Healthcare Inc.

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