Freshmint Sensitive: Package Insert and Label Information

FRESHMINT SENSITIVE- sodium fluoride and potassium nitrate paste, dentifrice
New World Imports, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.4 mg in 1 g POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 50 mg in 1 g

Inactive Ingredients Ingredient Name Strength Sorbitol Silicon Dioxide Water Polyethylene Glycol 1500 Sodium Lauryl Sulfate Glycerin Carboxymethylcellulose Sodium Titanium Dioxide Sodium Phosphate, Tribasic, Dodecahydrate Saccharin Sodium Sodium Benzoate Methylparaben Propylparaben D&C Yellow No. 10 FD&C Blue No. 1

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51824-053-02 1 TUBE in 1 BOX contains a TUBE (51824-053-01) 1 NDC:51824-053-01 122 g in 1 TUBE This package is contained within the BOX (51824-053-02)

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)

Revised: 10/2019 New World Imports, Inc