FRESHMINT PREMIUM ANTICAVITY- sodium fluoride paste, dentifrice

Freshmint Premium Anticavity by

Drug Labeling and Warnings

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

Drug Details [pdf]

OTC Active Ingredient

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

OTC Purpose

Anticavity

Keep out of reach of Children under 6 years of age

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Uses

Helps protect teeth and roots against cavities.

Warnings

Keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years & older:

• Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow.
• To minimize swallowing use a pea-sized amount in children under 6 years of age.
• Supervise children's brushing until good habits are established.

Children under 2 years:

• Ask a dentist

Inactive Ingredients

Sorbitol, Silica, Treated Water (aqua), Glycerin, Polyethulene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD&C Blue #1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT PREMIUM ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-034
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
POTASSIUM SODIUM SACCHARATE DIHYDATE (UNII: 6SI0K9D9KF)
Sodium benzoate (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (sky blue)	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-034-01	130 g in 1 TUBE; Type 0: Not a Combination Product	04/04/2013
2	NDC: 51824-034-09	8 g in 1 PACKET; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/04/2013

Labeler - New World Imports, Inc (075372276)

Registrant - New World Imports, Inc (075372276)