LUSTER NOW

Manufacturer: DENTOVATIONS INC | Lornamead Inc.
Effective date: 2019-02-26
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 22:58:38

Label at a glance#

ProductLUSTER NOW INSTANT WHITENING

Active ingredientSODIUM FLUORIDE

Label structure10 sections

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-823-5272

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

PURPOSE:

ANTI-CAVITY

INDICATIONS & USAGE SECTION

USES: ANTI-CAVITY.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Luster Now_DEN1055 NOW box

Luster Now_DEN1055 NOW tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	5
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	5
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	5
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	5
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57353-103-31	2020-09-27	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste
57353-103-53	2020-09-27	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste
57353-103-31	2020-09-25	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste
57353-103-53	2020-09-25	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste
57353-103-31	2020-07-22	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste
57353-103-53	2020-07-22	C162847	48780-1	ab0e2407-3542-f274-e053-dbdaa90a6471	Luster Now Instant Whitening Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57353-103-11	LUSTER NOWINSTANT WHITENING	42 g in 1 TUBE	GEL, DENTIFRICE	42	5
57353-103-13	LUSTER NOWINSTANT WHITENING	113 g in 1 TUBE	GEL, DENTIFRICE	113	5
57353-103-31	LUSTER NOWINSTANT WHITENING	3 in 1 BOX	GEL, DENTIFRICE	3	5
57353-103-53	LUSTER NOWINSTANT WHITENING	1 in 1 BOX	GEL, DENTIFRICE	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57353-103	LUSTER NOW INSTANT WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [DENTOVATIONS INC]	5	Legacy NDC, 4 package rows	20190227_f1133116-3bb2-4de4-ae97-040456ead4bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	3
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	3
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	3
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

LUSTER NOW INSTANT WHITENING
SODIUM FLUORIDE
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
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57353-103	57353-103-13, 57353-103-53, 57353-103-11, 57353-103-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM PHOSPHATE	SE337SVY37	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 413 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRASYNOVIAL	0.1 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, EMULSION / INTRAVENOUS	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOLUTION / NASAL	1.89 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	SOAP / TOPICAL	0.21 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, ORALLY DISINTEGRATING / ORAL		24 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	TABLET / ORAL	16 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / BUCCAL	5.18 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ENTERAL		2920 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM PHOSPHATE	SODIUM PHOSPHATE	SE337SVY37	INJECTION, SOLUTION / INTRAMUSCULAR	0.14 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION/ DROPS / OPHTHALMIC	1.4 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION/ DROPS / OPHTHALMIC		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL		111 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION / OPHTHALMIC	1.4 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
82d13181-b318-c29d-e053-2a91aa0aef33			f1133116-3bb2-4de4-ae97-040456ead4bb	2019-02-26	Warnings	Exact identifier spl id: 82d13181-b318-c29d-e053-2a91aa0aef33 spl set id: f1133116-3bb2-4de4-ae97-040456ead4bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.