Freshmint Anticavity Fluoride Toothpaste

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 2.2mg in 1g
Labeler: New World Imports, Inc
NDC Code: 51824-474

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.

Drug Facts

Sodium Fluoride - 0.22%  (0.1% w/v fluoride ion)

Anticavity

Keep out of reach of children 6 years of age.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Helps protect against cavities

Keep out of reach of children.

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean or at least twice a day, or as directed by a dentist or physician.

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years: Ask a dentist or physician

Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxy Methyl Cellulose, Methylparaben, Propylparaben.

FRESHMINT  ANTICAVITY FLUORIDE TOOTHPASTE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-474
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
CARBOMER HOMOPOLYMER TYPE C 
Sodium Lauryl Sulfate 
Polyethylene Glycol 1500 
Saccharin Sodium 
Silicon Dioxide 
Carboxymethylcellulose Sodium 
Methylparaben 
Propylparaben 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51824-474-017.9 g in 1 PACKET
2NDC:51824-474-0217 g in 1 TUBE
3NDC:51824-474-0324 g in 1 TUBE
4NDC:51824-474-0443 g in 1 TUBE
5NDC:51824-474-0578 g in 1 TUBE
6NDC:51824-474-06130 g in 1 TUBE
7NDC:51824-474-07181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/17/2010
Labeler - New World Imports, Inc (075372276)

Revised: 09/2010
 
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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