WESTERN DENTAL- sodium fluoride 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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Active ingredients

SODIUM MONOFLUOROPHOSPHATE 0.76%

Purpose

anticavity toothpaste

Uses

Aids in the prevention of dental cavities

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, 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 a doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing),

supervise children as necessary until capable of useing without supervision.Children under 2 years of age:consult a dentist or doctor.

INACTIVE INGREDIENT

calcium carbonate,CarboxyMethyl Cellulose ,glycerin,hydrated silica,purified water,Sodium Benzoate,Sodium Lauryl Sulfate,Sodium Saccharin,Sorbitol,Tetrasodium Diphosphate

1

WESTERN DENTAL 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-800
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
PHYTONADIOL TETRASODIUM DIPHOSPHATE (UNII: X952T8E4RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71035-800-016 in 1 CARTON02/11/2016
124 in 1 BOX
128.35 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 finalpart35602/11/2016
Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-800)

Revised: 6/2017
Document Id: 5250b063-8d76-2a8e-e054-00144ff8d46c
Set id: 52506e52-5fd9-293a-e054-00144ff8d46c
Version: 1
Effective Time: 20170619
 
Yangzhou Hongshengding Chemical Co.,Ltd.