IBRITE- sodium fluoride, potassium nitrate paste, dentifrice

iBrite by

Drug Labeling and Warnings

iBrite by is a Otc medication manufactured, distributed, or labeled by Pac-Dent International Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, dentifrice

Product 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)