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Freshmint Premium Anticavity Gel

Medically reviewed on Oct 23, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 2.43mg in 1g
Labeler: New World Imports, Inc
NDC Code: 51824-046

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, 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

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FRESHMINT PREMIUM ANTICAVITY GEL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-046
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
SILICON DIOXIDE 
WATER 
POLYETHYLENE GLYCOL 1500 
SODIUM LAURYL SULFATE 
GLYCERIN 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
SACCHARIN SODIUM DIHYDRATE 
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE 
METHYLPARABEN 
SODIUM PYROPHOSPHATE 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Product Characteristics
Colorblue (Aqua Blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-046-02144 TUBE in 1 CARTON
1NDC:51824-046-0128 g in 1 TUBE
2NDC:51824-046-0472 TUBE in 1 CARTON
2NDC:51824-046-0385 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2015
Labeler - New World Imports, Inc (075372276)

 
New World Imports, Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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