LUSTER NOW INSTANT WHITENING- sodium fluoride gel, dentifrice

LUSTER NOW by

Drug Labeling and Warnings

LUSTER NOW by is a Otc medication manufactured, distributed, or labeled by DENTOVATIONS INC, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LUSTER NOW  INSTANT WHITENING
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57353-103
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57353-103-53	1 in 1 BOX	06/20/2016
1	NDC: 57353-103-13	113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57353-103-31	3 in 1 BOX	06/20/2016
2	NDC: 57353-103-11	42 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2012

Labeler - DENTOVATIONS INC (128248676)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(57353-103)