Freshmint Premium Anticavity: Package Insert and Label Information

FRESHMINT PREMIUM ANTICAVITY- sodium fluoride 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.

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

FRESHMINT PREMIUM ANTICAVITY sodium fluoride paste, dentifrice

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-029 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.43 mg in 1 g

Inactive Ingredients Ingredient Name Strength SORBITOL SILICON DIOXIDE WATER GLYCERIN POLYETHYLENE GLYCOL 1500 SODIUM LAURYL SULFATE TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARRAGEENAN SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE Sodium benzoate SODIUM PYROPHOSPHATE METHYLPARABEN PROPYLPARABEN FD&C BLUE NO. 1 SACCHARIN SODIUM

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51824-029-02 144 TUBE in 1 CARTON contains a TUBE (51824-029-01) 1 NDC:51824-029-01 24 g in 1 TUBE This package is contained within the CARTON (51824-029-02) 2 NDC:51824-029-05 144 BOX in 1 CARTON contains a BOX (51824-029-04) 2 NDC:51824-029-04 36 TUBE in 1 BOX This package is contained within the CARTON (51824-029-05) and contains a TUBE (51824-029-03) 2 NDC:51824-029-03 43 g in 1 TUBE This package is contained within a BOX (51824-029-04) and a CARTON (51824-029-05) 3 NDC:51824-029-07 72 TUBE in 1 CARTON contains a TUBE (51824-029-06) 3 NDC:51824-029-06 85 g in 1 TUBE This package is contained within the CARTON (51824-029-07)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/2013

Labeler — New World Imports, Inc (075372276)

Registrant — New World Imports, Inc (075372276)

Revised: 10/2019 New World Imports, Inc