PCXX 1.64 STANNOUS RNS MINT: Package Insert and Label Information

PCXX 1.64 STANNOUS RNS MINT- stannous fluoride liquid
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.

RNS SNF MT front panel
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Stannous Strawberry Back Panel
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PCXX 1.64 STANNOUS RNS MINT
fluoride treatment liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-301
Route of Administration topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 16 in 1 mg
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN .03 mg in 1 mg
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62007-301-64 1 mg in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2015
Labeler — Ross Healthcare Inc. (244249012)
Registrant — Ross Healthcare Inc. (244249012)
Establishment
Name Address ID/FEI Operations
Ross Healthcare Inc. 244249012 manufacture (62007-301)

Revised: 01/2015 Ross Healthcare Inc.

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