MINTBLAST ANTI CAVITY FLUORIDE- sodium fluoride paste

MintBlast Anti Cavity Fluoride by

Drug Labeling and Warnings

MintBlast Anti Cavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd, Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Sodium Fluoride 0.243%(0.15% 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 you accidentally swallow more than used for brushing.seek professional assisatance or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

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

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

Glycerine,Sorbitol,Saccharin Sodium,Sodium benzoate,Sodium Carboxy Methyl Cellulose,Xanthan Gum,Sodium Fluoride,Treated Water,Silica,Sodium Lauryl Sulfate,Tianium Dioxide,Flavor,CI42090

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINTBLAST ANTI CAVITY FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51289-300
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51289-300-01	144 in 1 BOX	04/15/2016
1		9.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51289-300-02	72 in 1 BOX	04/15/2016
2		9.9 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51289-300-03	144 in 1 BOX	03/07/2016
3		28.35 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 51289-300-04	72 in 1 BOX	03/07/2016
4		28.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/07/2016

Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383)

Registrant - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.		527127383	manufacture(51289-300)