![WESTERN DENTAL (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]](https://medic.hrt.org//dailymed/images/52506e52-5fd9-293a-e054-00144ff8d46c/label1706.jpg)
| NDC | 71035-800-01 |
| Set ID | 52506e52-5fd9-293a-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Yangzhou Hongshengding Chemical Co.,Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART356 |
- Active ingredients
- Uses
- Warnings
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WESTERN DENTAL
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71035-800 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71035-800-01 6 in 1 CARTON 02/11/2016 1 24 in 1 BOX 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/11/2016 Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755) Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755) Establishment Name Address ID/FEI Business Operations Yangzhou Hongshengding Chemical Co.,Ltd. 543774755 manufacture(71035-800)
