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% (0.13% 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

 Glycerine, Sorbitol, Saccharin Sodium, Sodium Benzoate,  Sodium Carboxy Methyl Cellulose, Xanthan Gum, Treated Water, Silica, Sodium Lauryl Sulfate, Titanium Dioxide, Flavor, CI42090

Mint Blast Product  Label 

mind blast

MINTBLAST 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72326-8011
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)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72326-8011-128 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
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(72326-8011)

Revised: 5/2018
Document Id: d92512ed-e5ee-4fd0-8706-77f84f78254d
Set id: 7b0b1034-c246-4518-821a-181c78ad6d4e
Version: 1
Effective Time: 20180528
 
YOUNG PS ACQUISITION, LLC