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ELECTRIFYING BLUE POLISH

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE .24g in 100g
Labeler: DENTOVATIONS INC
NDC Code: 57353-105

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.

ACTIVE INGREDIENT: SODIUM FLUORIDE 0.24% (W/W)

PURPOSE:

ANTI-CAVITY

USES: ANTI-CAVITY.

DIRECTIONS: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER:

FOR THE BEST RESULTS BRUSH TEETH THOROUGHLY, PREFERABLY AFTER EACH MEAL OR AT LEAST TWICE A DAY, OR AS DIRECTED BY A DENTIST OR DOCTOR. DO NOT SWALLOW. PRODUCT IS NOT RECOMMENDED FOR USE BY CHILDREN UNDER 12 YEARS OF AGE.

KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.

WARNINGS: IF MORE THAN THE AMOUNT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. AVOID CONTACT OF THE PRODUCT WITH THE EYE. IF IRRITATION (SUCH AS REDNESS, SWELLING, SORENESS) OF THE GUM OR THE MOUTH OCCURS, DISCONTINUE USE AND CONSULT A DENTIST.

OTHER INFORMATION: STORE BETWEEN 59-80°F (15-27°C).

INACTIVE INGREDIENTS: Sorbitol, Silica, Water, Propylene Glycol, Sodium Lauryl Sulfate, Flavor, Disodium Phosphate, PVM/MA Copolymer,

Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Xanthan Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, FD&C Blue No. 1

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ELECTRIFYING BLUE POLISH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57353-105
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
WATER 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
POLYVINYL ALCOHOL 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
ACESULFAME POTASSIUM 
XANTHAN GUM 
SODIUM PYROPHOSPHATE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:57353-105-521 TUBE in 1 BOX
1NDC:57353-105-1245 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/22/2015
Labeler - DENTOVATIONS INC (128248676)

Revised: 01/2015
 
DENTOVATIONS 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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