MINTBLAST- sodium fluoride paste 
YOUNG PS ACQUISITION, LLC

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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MINTBLAST ANTICAVITY FLUORIDE TOOTH PASTE

Active ingredient

Sodium Fluoride -0.243 mg (0.15% w/v Fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of cavities.

Directions : 

Warnings 

Keep out of the reach of  children under 6 years of age. If you accidentally swallow  more than used for brushing, seek professional assistance  or contact a Poison Control Center immediately.

Inactive Ingredients

 Sorbitol, Silica , Treated Water , Poly Ethylene Glycol 1500 , Sodium Lauryl Sulfate , Flavor,  Titanium Dioxide , Cellulose Gum and/or Carrageenan, Tri Sodium Ortho Phosphate,   Saccharin Sodium, Tetra Sodium Pyrophosphate,Glycerine,  Color : FD&C Blue No.1

Mint Blast Product  Label 

image description

MINTBLAST 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72326-8001
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72326-8001-128 g in 1 TUBE; Type 0: Not a Combination Product05/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/26/2018
Labeler - YOUNG PS ACQUISITION, LLC (119620784)
Establishment
NameAddressID/FEIBusiness Operations
Dabur India Limited650599231manufacture(72326-8001)

Revised: 11/2021
Document Id: d174dd33-15a2-0f7c-e053-2995a90a9fee
Set id: 450821aa-e903-4a97-a152-8ea8ab5dd989
Version: 3
Effective Time: 20211123
 
YOUNG PS ACQUISITION, LLC