IBRITE- sodium fluoride, potassium nitrate paste, dentifrice
Pac-Dent International Inc.

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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IBRITE
sodium fluoride, potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68983-006
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/01/2016

Labeler - Pac-Dent International Inc. (073253994)

Registrant - Pac-Dent International Inc. (073253994)

Name	Address	ID/FEI	Business Operations
Establishment
Pac-Dent International Inc.		073253994	manufacture(68983-006)