CHARCOAL MINT DENTISTRY- sodium fluoride paste

charcoal MINT dentistry by

Drug Labeling and Warnings

charcoal MINT dentistry by is a Otc medication manufactured, distributed, or labeled by Yangzhou Hongshengding Chemical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Sodium Fluoride 0.24%

Purpose

anticavity

Uses

aids in the prevention of dental vavities.

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center right away.

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 doctor.

Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision.

Children under 2 years:Consult a dentist or doctor.

INACTIVE INGREDIENT

HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHARCOAL MINT DENTISTRY 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71035-903
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
HYDROXYETHYL CELLULOSE (40 MPA.S AT 2%) (UNII: I2N4ZF9233)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	black	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71035-903-01	72 in 1 CARTON	09/04/2016
1		1 in 1 BOX
1		170.1 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71035-903-02	288 in 1 CARTON	09/04/2016
2		1 in 1 BOX
2		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	09/04/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-903)