FRESHMINT- sodium fluoride gel, dentifrice

Freshmint by

Drug Labeling and Warnings

Freshmint 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 Fluoride - 0.243%  (0.11% w/v fluoride ion)

PURPOSE

Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children 6 years of age.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Helps protect against cavities

WARNINGS

Keep out of reach of children under 6 years of age.  If more than used for brushing is accidentally swallowed, get meidcal help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean 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 or physician

INACTIVE INGREDIENT

Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulfate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxymethyl Cellulose, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-066
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
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Polyethylene Glycol 1500 (UNII: 1212Z7S33A)
Saccharin Sodium (UNII: SB8ZUX40TY)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-066-28	7.9 g in 1 PACKET; Type 0: Not a Combination Product	08/08/2018
2	NDC: 51824-066-25	71 g in 1 TUBE; Type 0: Not a Combination Product	08/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/08/2018

Labeler - New World Imports, Inc (075372276)