TOOTHPOWDER- sodium fluoride powder

toothpowder by

Drug Labeling and Warnings

toothpowder 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 0.24%(0.1 w/v Fluoride ion)

Purpose

anticavity

Uses

helps protect against cavities.

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 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

calcium carbonate,silica,mint falvour,sodium laryl sulfate ,sodium benzoate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOOTHPOWDER 
sodium fluoride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51289-500
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM SILICATE (UNII: IJF18F77L3)
MINT (UNII: FV98Z8GITP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51289-500-03	250 in 1 CARTON	09/09/2016
1		85 g in 1 BAG; Type 0: Not a Combination Product
2	NDC: 51289-500-02	250 in 1 CARTON	09/09/2016
2		57 g in 1 BAG; Type 0: Not a Combination Product
3	NDC: 51289-500-01	250 in 1 CARTON	09/09/2016
3		28 g in 1 BAG; 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 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(51289-500)