Label: LUSTER NOW INSTANT WHITENING- 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 February 26, 2019

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    PURPOSE:

    ANTI-CAVITY

  • INDICATIONS & USAGE

    USES: ANTI-CAVITY.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.

  • 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.

  • STORAGE AND HANDLING

    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?

    1-800-823-5272 * M-F 9 A.M. - 5 P.M. EST * LUSTERPREMIUMWHITE.COM

  • PRINCIPAL DISPLAY PANEL

    Luster Now_DEN1055 NOW box

    Luster Now_DEN1055 NOW tube

  • INGREDIENTS AND APPEARANCE
    LUSTER NOW  INSTANT WHITENING
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57353-103
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 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 (UNII: SE337SVY37)  
    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:57353-103-531 in 1 BOX06/20/2016
    1NDC:57353-103-13113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:57353-103-313 in 1 BOX06/20/2016
    2NDC:57353-103-1142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2012
    Labeler - DENTOVATIONS INC (128248676)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.078584069manufacture(57353-103)
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