LUSTER NOW INSTANT WHITENING- sodium fluoride gel, dentifrice 
DENTOVATIONS INC

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.

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Luster Now Instant Whitening Toothpaste

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

PURPOSE:

ANTI-CAVITY

USES: ANTI-CAVITY.

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 UNDER 12 YEARS.

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.

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

QUESTIONS OR COMMENTS?

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

Luster Now_DEN1055 NOW box

Luster Now_DEN1055 NOW tube

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)

Revised: 2/2019
Document Id: 82d13181-b318-c29d-e053-2a91aa0aef33
Set id: f1133116-3bb2-4de4-ae97-040456ead4bb
Version: 5
Effective Time: 20190226
 
DENTOVATIONS INC