FRESHMINT PREMIUM ANTICAVITY GEL- sodium fluoride paste, dentifrice 
New World Imports, Inc

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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:

Children under 2 years:

Inactive Ingredients

Sorbitol, Silica, 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

ADA Tube
FRESHMINT PREMIUM ANTICAVITY GEL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-046
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorblue (Aqua Blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-046-02144 in 1 CARTON01/01/2015
1NDC:51824-046-0128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51824-046-0472 in 1 CARTON01/01/2015
2NDC:51824-046-0385 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02101/01/2015
Labeler - New World Imports, Inc (075372276)

Revised: 11/2023
Document Id: da399095-72a7-4c45-b006-4043fab8012e
Set id: dfe564c1-2097-431d-93f0-cf423f254248
Version: 4
Effective Time: 20231129
 
New World Imports, Inc