![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/26581d28-a949-3988-e054-00144ff88e88.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/PDP.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/active ingredient list.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/dosage.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/inactive ingredients list.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/purpose.jpg)
![IBRITE (SODIUM FLUORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [PAC-DENT INTERNATIONAL INC.]](https://medic.hrt.org//dailymed/images/25f0e453-ed76-141b-e054-00144ff8d46c/warnings.jpg)
| NDC | 68983-006-01, 68983-006-02, 68983-006-03, 68983-006-04 |
| Set ID | 25f0e453-ed76-141b-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Pac-Dent International Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART356 |
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBRITE
sodium fluoride, potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68983-006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.54 mg in 1 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Product Characteristics Color green Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68983-006-02 1 in 1 CARTON 02/01/2016 1 NDC:68983-006-01 140 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68983-006-04 1 in 1 CARTON 02/01/2016 2 NDC:68983-006-03 25 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 02/01/2016 Labeler - Pac-Dent International Inc. (073253994) Registrant - Pac-Dent International Inc. (073253994) Establishment Name Address ID/FEI Business Operations Pac-Dent International Inc. 073253994 manufacture(68983-006)
