![TEETH DESENSITIZING AND REMINERALIZING GEL (POTASSIUM NITRATE,SODIUM FLUORIDE,SODIUM MONOFLUOROPHOSPHATE) PASTE [FUZHOU DIFENG BIO-TECH CO., LTD.]](https://medic.hrt.org//dailymed/images/2d4e6542-faa9-63f2-e054-00144ff8d46c/label1.jpg)
| NDC | 49410-200-01, 49410-200-02, 49410-200-03, 49410-200-04, 49410-200-05, 49410-200-06, 49410-200-07, 49410-200-08 |
| Set ID | 2d4e6542-faa9-63f2-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Fuzhou Difeng Bio-tech Co., Ltd. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART356 |
- Active ingredients
- Uses
- Warnings
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Directions
Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on
sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse
your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician.
Children under 18 years of age and pregnant, breast feeding women: consult a dentist or
physician prior to use. - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TEETH DESENSITIZING AND REMINERALIZING GEL
potassium nitrate,sodium fluoride,sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49410-200 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) MENTHOL (UNII: L7T10EIP3A) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49410-200-01 5 in 1 CARTON 01/08/2018 1 200 in 1 CONTAINER 1 1.5 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 2 NDC:49410-200-02 5 in 1 CARTON 01/08/2018 2 100 in 1 CONTAINER 2 2 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 3 NDC:49410-200-03 5 in 1 CARTON 01/08/2018 3 100 in 1 CONTAINER 3 4 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 4 NDC:49410-200-04 5 in 1 CARTON 01/08/2018 4 80 in 1 CONTAINER 4 6 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 5 NDC:49410-200-05 6 in 1 CARTON 01/08/2018 5 300 in 1 CONTAINER 5 4.5 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 6 NDC:49410-200-06 6 in 1 CARTON 01/08/2018 6 200 in 1 CONTAINER 6 10 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 7 NDC:49410-200-07 6 in 1 CARTON 01/08/2018 7 333 in 1 CONTAINER 7 3 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product 8 NDC:49410-200-08 300 in 1 CARTON 01/08/2018 8 3.5 g in 1 VIAL, SINGLE-USE; 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 03/07/2016 Labeler - Fuzhou Difeng Bio-tech Co., Ltd. (528195950) Registrant - Fuzhou Difeng Bio-tech Co., Ltd. (528195950) Establishment Name Address ID/FEI Business Operations Fuzhou Difeng Bio-tech Co., Ltd. 528195950 manufacture(49410-200)
