MINT FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

Mint Fluoride Tooth by

Drug Labeling and Warnings

Mint 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   0.243%(0.11 w/v Fluoride ion)

Purpose

Anti-cavity toothpaste

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.

Do not use if the inner foil is torn, cut, or missing

Keep out of reach of children.

Directions

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

Do not swallow

To minimize wallowing, use a pea sizes amount in children under 6 years

Supervise children's brushing

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

MINT FLUORIDE TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70766-011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 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: 70766-011-07	4 in 1 BOX	12/10/2022
1		12 in 1 POUCH
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70766-011-02	12 in 1 BOX	12/10/2022
2		12 in 1 POUCH
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 70766-011-03	24 in 1 BOX	12/10/2022
3		12 in 1 POUCH
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 70766-011-04	144 in 1 BOX	12/10/2022
4		24 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 70766-011-05	288 in 1 BOX	12/10/2022
5		24 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 70766-011-06	576 in 1 BOX	12/10/2022
6		24 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 Drug	M021	11/13/2022

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(70766-011)