TROPICAL MINT DENTISTRY- 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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71035-902

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

TROPICAL MINT DENTISTRY
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71035-902
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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		Score
Shape		Size
Flavor	WATERMELON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71035-902-01	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:71035-902-02	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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	09/04/2016

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(71035-902)