FRESHMINT SENSITIVE- potassium nitrate and sodium fluoride paste, dentifrice

Freshmint Sensitive by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Potassium Nitrate - 5%

Sodium Fluoride - 0.24%

Purpose

Potassium Nitrate - Antihypersensitivity

Sodium Fluoride - Anticavity

Keep out of reach of Children

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

Uses

Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.

Aids in the prevention of dental cavities

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor

Stop and ask a dentist if problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist

Directions

Adults and children 12 years and older: Brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist.  Be sure to brush sensitive areas.  Children under 12 years of age: Consult a dentist or doctor

Inactive Ingredients

Sorbitol, Silica, Treated Water, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methylparaben, Propylparaben, Color: D and C Yellow # 10, FD and C Blue # 1.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT SENSITIVE 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-053
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 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)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium Phosphate, Tribasic, Dodecahydrate (UNII: B70850QPHR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sodium Benzoate (UNII: OJ245FE5EU)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-053-02	1 in 1 BOX	09/16/2010
1	NDC: 51824-053-01	122 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 not final	part356	09/16/2010

Labeler - New World Imports, Inc (075372276)