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Freshmint Premium Anticavity Gel

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)

Revised: 10/2014
 
New World Imports, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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