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iBrite

Medically reviewed on December 4, 2017

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 2.54mg in 1g, POTASSIUM NITRATE 30mg in 1g
Labeler: Pac-Dent International Inc.
NDC Code: 68983-006

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.

IBRITE 
sodium fluoride, potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68983-006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.54 mg  in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C GREEN NO. 3 
GLYCERIN 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 400 
WATER 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SODIUM CITRATE 
SODIUM PHOSPHATE, TRIBASIC 
CARBOXYMETHYLCELLULOSE SODIUM 
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68983-006-021 TUBE in 1 CARTON
1NDC:68983-006-01140 g in 1 TUBE
2NDC:68983-006-041 TUBE in 1 CARTON
2NDC:68983-006-0325 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/2016
Labeler - Pac-Dent International Inc. (073253994)
Registrant - Pac-Dent International Inc. (073253994)
Establishment
NameAddressID/FEIOperations
Pac-Dent International Inc.073253994manufacture(68983-006)

 
Pac-Dent International Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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