PCXX ONE MINTE GEL VANILLA ORANGE- fluoride treatment gel

PCXX ONE MINTE GEL VANILLA ORANGE by

Drug Labeling and Warnings

PCXX ONE MINTE GEL VANILLA ORANGE 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 ONE MINTE GEL VANILLA ORANGE 
fluoride treatment gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62007-011
Route of Administration	topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	27.2 mg  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)	.01 mg  in 1 mg
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	.02 mg  in 1 mg

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	VANILLA, ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62007-011-16	1 mg in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/21/2014

Labeler - Ross Healthcare Inc. (244249012)

Registrant - Ross Healthcare Inc. (244249012)

Establishment
Name	Address	ID/FEI	Business Operations
Ross Healthcare Inc.		244249012	manufacture(62007-011)