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, Dabur India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride -0.243 mg (0.15% 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

 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 

INGREDIENTS AND APPEARANCE

MINTBLAST 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72326-8001
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)
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
Shape		Size
Flavor	MINT (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72326-8001-1	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
Dabur India Limited		650599231	manufacture(72326-8001)