MINTBLAST ANTI CAVITY FLUORIDE- sodium fluoride paste
Yangzhou Hongshengding Chemical Co.,Ltd.

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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Anti Cavity Fluoride Toothpaste

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

MINTBLAST ANTI CAVITY FLUORIDE
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71035-300
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71035-300-01	144 in 1 BOX	04/15/2016
1		9.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:71035-300-02	72 in 1 BOX	04/15/2016
2		9.9 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:71035-300-03	144 in 1 BOX	03/07/2016
3		28.35 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:71035-300-04	72 in 1 BOX	03/07/2016
4		28.35 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/11/2016

Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-300)