FRESHMINT ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

Freshmint Anticavity Fluoride by

Drug Labeling and Warnings

Freshmint Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate - .76%

(Total Fluoride Content - 1000 ppm Approx.)

PURPOSE

Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children under 6 years of Age.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Helps protect against cavities

WARNINGS

Keep out of reach of children under 6 years of age. 

DOSAGE & ADMINISTRATION

Adults and Children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years: Ask a dentist of physician.

INACTIVE INGREDIENT

Calcium Carbonate, Treated Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methylparaben, Titanium Dioxide, Polyethylene Glycol 400, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-067
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Sodium Silicate (UNII: IJF18F77L3)
Sodium phosphate, tribasic, dodecahydrate (UNII: B70850QPHR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Methylparaben (UNII: A2I8C7HI9T)
Titanium Dioxide (UNII: 15FIX9V2JP)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Propylparaben (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white (White)	Score
Shape		Size
Flavor	MINT (Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-067-01	17 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
2	NDC: 51824-067-02	17 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
3	NDC: 51824-067-03	24 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
4	NDC: 51824-067-04	43 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
5	NDC: 51824-067-05	43 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
6	NDC: 51824-067-06	78 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
7	NDC: 51824-067-07	78 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
8	NDC: 51824-067-08	130 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010
9	NDC: 51824-067-09	181 g in 1 TUBE; Type 0: Not a Combination Product	09/16/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/16/2010

Labeler - New World Imports, Inc (075372276)