Label: IBRITE- sodium fluoride, potassium nitrate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 68983-006-01, 68983-006-02, 68983-006-03, 68983-006-04 - Packager: Pac-Dent International Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 2, 2015
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- WARNINGS
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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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)
