Label at a glance#

ProductBURST Wonderfully Whitening Anti Cavity

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 years of age.

Warnings

WARNINGS SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cellulose gum, flavor, glycerin, PEG-32, propylene glycol, PVM/MA copolymer, silica, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, water, xanthan gum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
891775	sodium fluoride 0.243 % Toothpaste	PSN	4
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	4
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	4
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	4
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	4
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71275-001-47	2022-01-28	C162847	48780-1	d6a99b39-5171-a426-e053-dadaa90af4c2	Burst Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71275-001-47	BURSTWonderfully Whitening Anti Cavity	133 g in 1 TUBE	PASTE, DENTIFRICE	133		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71275-001	BURST WONDERFULLY WHITENING ANTI CAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [BURST.USA.INC]	4	Legacy NDC, 1 package rows	20200124_48c22ca2-1238-6d6e-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

BURST Wonderfully Whitening Anti Cavity
Sodium fluoride
BENZYL ALCOHOL
CARBOXYMETHYLCELLULOSE
GLYCERIN
POLYETHYLENE GLYCOL 1500
PROPYLENE GLYCOL
TRICLOSAN
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SACCHARIN SODIUM
SORBITOL
FLUORIDE ION
XANTHAN GUM
WATER
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71275-001	71275-001-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZYL ALCOHOL	LKG8494WBH	IACT
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
TRICLOSAN	4NM5039Y5X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
XANTHAN GUM	TTV12P4NEE	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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
9cbe75fe-457d-5654-e053-2995a90a3de4			48c22ca2-1238-6d6e-e054-00144ff8d46c	2020-01-22	Warnings	Exact identifier spl id: 9cbe75fe-457d-5654-e053-2995a90a3de4 spl set id: 48c22ca2-1238-6d6e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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