FRESHMINT ANTICAVITY FLUORIDE- sodium fluoride gel, 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.

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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.

Clear Gel Tube

FRESHMINT  ANTICAVITY FLUORIDE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-474
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Polyethylene Glycol 1500 (UNII: 1212Z7S33A)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-474-017.9 g in 1 PACKET; Type 0: Not a Combination Product09/17/201001/01/2021
2NDC:51824-474-0217 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
3NDC:51824-474-0324 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
4NDC:51824-474-0443 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
5NDC:51824-474-0578 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
6NDC:51824-474-06130 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
7NDC:51824-474-07181 g in 1 TUBE; Type 0: Not a Combination Product09/17/201001/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/17/201001/01/2021
Labeler - New World Imports, Inc (075372276)

Revised: 11/2018
 
New World Imports, Inc