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Fluoride Gel by Yangzhou Hongshengding Chemical Co.,Ltd.

Medically reviewed on January 6, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: Yangzhou Hongshengding Chemical Co.,Ltd.
NDC Code: 71035-400

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 Fluoride Gel Toothpaste

Active ingredients

Sodium Fluoride 0.22%(0.15 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

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

FLUORIDE GEL 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-400
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOCYSTEINE LYSINE MONOHYDRATE 
SORBITOL 
SODIUM LAURYL SULFATE 
METHYL PARAOXON 
PROPYLPARABEN SODIUM 
WATER 
SODIUM SILICATE 
POTASSIUM SODIUM SACCHARATE 
Packaging
#Item CodePackage Description
1NDC:71035-400-01720 TUBE in 1 BOX
117 g in 1 TUBE
2NDC:71035-400-02720 TUBE in 1 BOX
224 g in 1 TUBE
3NDC:71035-400-03144 TUBE in 1 BOX
343 g in 1 TUBE
4NDC:71035-400-041000 TUBE in 1 BOX
40.22 g in 1 TUBE
5NDC:71035-400-051000 TUBE in 1 BOX
57 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/01/2015
Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Establishment
NameAddressID/FEIOperations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-400)

 
Yangzhou Hongshengding Chemical 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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