PCXX MINUTE FM LIME- sodium fluoride aerosol, foam

PCXX MINUTE FM LIME by

Drug Labeling and Warnings

PCXX MINUTE FM LIME by is a Prescription medication manufactured, distributed, or labeled by Ross Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.0272 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	.04 g  in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	1.2 mg  in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)	8.5 mg  in 1 g
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)	.011 g  in 1 g
XANTHAN GUM (UNII: TTV12P4NEE)	4.2 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	LIME	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62007-270-07	125 g in 1 BOTTLE, SPRAY

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	Business Operations
Ross Healthcare Inc.		244249012	manufacture(62007-270)