BRIDENT- sodium monofluorophosphate 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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71035-900 brident toothpaste

Active ingredients

Sodium Monofluorophosphate 0.76%

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,CALCIUM CARBONATE,WATER,CARBOXYMETHYLCELLULOSE, PHYTONADIOL TETRASODIUM DIPHOSPHATE,SODIUM BENZOATE,SODIUM LAURYL SULFATE,SACCHARIN SODIUM,SORBITOL,GLYCERIN

1

BRIDENT 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-900
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHYTONADIOL TETRASODIUM DIPHOSPHATE (UNII: X952T8E4RN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71035-900-016 in 1 CARTON09/04/2016
124 in 1 BOX, UNIT-DOSE
11 in 1 BOX
128.34 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/04/2016
Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-900)

Revised: 6/2018
Document Id: 6da578f1-b1fd-a649-e053-2a91aa0a3db2
Set id: 6da578f1-b1fe-a649-e053-2a91aa0a3db2
Version: 1
Effective Time: 20180602
 
Yangzhou Hongshengding Chemical Co.,Ltd.