MINTBLAST- sodium fluoride paste

MINTBLAST by

Drug Labeling and Warnings

MINTBLAST by is a Otc medication manufactured, distributed, or labeled by YOUNG PS ACQUISITION, LLC, Yangzhou Hongshengding Chemical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride - 0.243% (0.13% w/v Fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of cavities.

Directions : 

• Adults and children 2 years of age  and  older: Brush teeth thoroughly, preferably after each  meal or at least twice a day,  or use as directed by a dentist or a 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 year : Ask a dentist or physician .

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.

WARNINGS

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 

INGREDIENTS AND APPEARANCE

MINTBLAST 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72326-8011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72326-8011-1	28 g in 1 TUBE; Type 0: Not a Combination Product	05/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/26/2018

Labeler - YOUNG PS ACQUISITION, LLC (119620784)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(72326-8011)