Label: ELECTRIFYING BLUE POLISH- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 30, 2019

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    PURPOSE:

    ANTI-CAVITY

  • INDICATIONS & USAGE

    USES: ANTI-CAVITY.

  • DOSAGE & ADMINISTRATION

    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

    KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.

  • WARNINGS

    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 SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    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

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    1-800-823-5727  *  M-F  9 A.M. - 5 P.M. EST  *  LUSTERPREMIUMWHITE.COM

  • PRINCIPAL DISPLAY PANEL

    760700 PW W4089-2 Folding Carton 2015 12 8

    760700 W4079-1 Power White Tube MECH Apr 8 2015

  • INGREDIENTS AND APPEARANCE
    ELECTRIFYING BLUE POLISH 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57353-105
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57353-105-521 in 1 BOX01/22/2015
    1NDC:57353-105-1245 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/22/2015
    Labeler - DENTOVATIONS INC (128248676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecometics, Inc064843923manufacture(57353-105)
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