MINTBLAST COOL MINT FLAVOR ANTI CAVITY FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

MintBlast Cool Mint Flavor Anti Cavity Fluoride Tooth by

Drug Labeling and Warnings

MintBlast Cool Mint Flavor Anti Cavity Fluoride Tooth by is a Otc medication manufactured, distributed, or labeled by Yangzhou SION Commodity Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

SODIUM FLUORIDE   0.24%(0.1 w/v Fluoride ion)

Purpose

anticavity 

Uses

aids in the prevention of cavities.

Warnings

Keep out of the reach of children under 6 years of age. If accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

Adults and children 2 years of age and older:

Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician

Children two to six years:

To minimize swallowing, use a pea sized amount. Supervise children brushing until good habits are estabished.

Chidren under two years:

Ask a dentist or a physician

INACTIVE INGREDIENT

Sorbitol, Hydrated silica,Water, PEG-8, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Menthol, Dicalcium Phosphate, Methylparaben, Propylparaben, Titanium Dioxide, sodium sacharine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINTBLAST COOL MINT FLAVOR ANTI CAVITY FLUORIDE TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70766-006
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MENTHOL (UNII: L7T10EIP3A)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70766-006-01	28 g in 1 TUBE; Type 0: Not a Combination Product	12/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/12/2020

Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)

Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou SION Commodity Co.,Ltd		546806042	manufacture(70766-006)