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toothpowder by Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd

Dosage form: powder
Ingredients: SODIUM FLUORIDE 0.24g in 100g
Labeler: Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd
NDC Code: 51289-500

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.

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

TOOTHPOWDER 
sodium fluoride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51289-500
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
SODIUM SILICATE 
MINT 
SODIUM BENZOATE 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:51289-500-03250 BAG in 1 CARTON
185 g in 1 BAG
2NDC:51289-500-02250 BAG in 1 CARTON
257 g in 1 BAG
3NDC:51289-500-01250 BAG in 1 CARTON
328 g in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/04/2016
Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383)
Registrant - Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd (527127383)
Establishment
NameAddressID/FEIOperations
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.527127383manufacture(51289-500)

Revised: 09/2016
 
Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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