FRESHMINT PREMIUM ANTICAVITY GEL- sodium fluoride paste, dentifrice

Freshmint Premium Anticavity Gel by

Drug Labeling and Warnings

Freshmint Premium Anticavity Gel 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, Siliica, Treated Water, Polyethylene Glycol 1500, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Methylparaben, Tetrasodium Pyrophosphate, Propylparaben, FD&C Blue # 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT PREMIUM ANTICAVITY GEL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-046
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)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	blue (Aqua Blue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-046-02	144 in 1 CARTON	01/01/2015
1	NDC: 51824-046-01	28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51824-046-04	72 in 1 CARTON	01/01/2015
2	NDC: 51824-046-03	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2015

Labeler - New World Imports, Inc (075372276)