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LUSTER NOW INSTANT WHITENING

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE .24g in 100g
Labeler: DENTOVATIONS INC
NDC Code: 57353-103

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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LUSTER NOW  INSTANT WHITENING
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57353-103
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 
POLYVINYL ALCOHOL 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
ACESULFAME POTASSIUM 
XANTHAN GUM 
SODIUM PYROPHOSPHATE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:57353-103-531 TUBE in 1 BOX
1NDC:57353-103-13113 g in 1 TUBE
2NDC:57353-103-313 TUBE in 1 BOX
2NDC:57353-103-1142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/01/2012
Labeler - DENTOVATIONS INC (128248676)

 
DENTOVATIONS INC

Medically reviewed on Jun 20, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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