TOOTHPOWDER- sodium fluoride powder
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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Charm-Tex toothpowder

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

$1$

TOOTHPOWDER
sodium fluoride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71035-500
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM SILICATE (UNII: IJF18F77L3)
MINT (UNII: FV98Z8GITP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71035-500-03	250 in 1 CARTON	09/09/2016
1		85 g in 1 BAG; Type 0: Not a Combination Product
2	NDC:71035-500-02	250 in 1 CARTON	09/09/2016
2		57 g in 1 BAG; Type 0: Not a Combination Product
3	NDC:71035-500-01	250 in 1 CARTON	09/09/2016
3		28 g in 1 BAG; 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(71035-500)