PCXX MINUTE FM LIME

PCXX MINUTE FM LIME- sodium fluoride aerosol, foam
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.

APF FM LM front panel
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APF FM LM secondary panel

PCXX MINUTE FM LIME
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-270
Route of Administration topical DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION .0272 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN .04 g in 1 g
SODIUM LAURYL SULFATE 1.2 mg in 1 g
HYDROFLUORIC ACID 8.5 mg in 1 g
SODIUM PHOSPHATE, MONOBASIC .011 g in 1 g
XANTHAN GUM 4.2 mg in 1 g
Product Characteristics
Color Score
Shape Size
Flavor LIME Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62007-270-07 125 g in 1 BOTTLE, SPRAY 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 (62007-270)

Revised: 02/2015 Ross Healthcare Inc.

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