Burkhart

Manufacturer: Burkhart Dental Supply Inc
Effective date: 2022-02-02
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:39:51

Label at a glance#

ProductBurkhart

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.

Dosage and administration

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100...

Storage and handling

Store at controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.

Label contents#

Full prescribing information#

Active Ingredient:

SPL UNCLASSIFIED SECTION

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

SPL UNCLASSIFIED SECTION

Fluoride Treatment Gel

Indications and Usage:

INDICATIONS & USAGE SECTION

A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings:

WARNINGS SECTION

Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
Read directions carefully before using.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59° to 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB.Burkhart APF Gel_BubbleGum.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43498-103-15	Burkhart	454 g in 1 BOTTLE, PLASTIC	GEL	454		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43498-103	BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	4	Current NDC, Legacy NDC, 1 package rows	20220203_79fa0a42-bb69-49db-9997-1679a75bac26.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	1
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Burkhart
Sodium Fluoride
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
SODIUM BENZOATE
SACCHARIN SODIUM
WATER
XANTHAN GUM
XYLITOL
TITANIUM DIOXIDE
FD&C RED NO. 40
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43498-103	43498-103-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
XYLITOL	VCQ006KQ1E	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C RED NO. 40	WZB9127XOA	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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii+dosage form 4 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	PASTE, DENTIFRICE / DENTAL	ADJ PH		Exact identifier — unii+route 4 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	GEL / TOPICAL	ADJ PH		Exact identifier — unii+dosage form 4 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii+route 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii+route 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii+dosage form 6 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	PASTE, DENTIFRICE / DENTAL	ADJ PH		Exact identifier — unii+route 4 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 24 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
Burkhart	SODIUM FLUORIDE	Burkhart Dental Supply Inc	79fa0a42-bb69-49db-9997-1679a75bac26	2022-02-02	Warnings	Exact identifier ndc (package): 43498-103-15 ndc (product): 43498-103 ndc11 (package): 43498010315 spl id: d70e42c6-8627-53b4-e053-2a95a90a4971 spl set id: 79fa0a42-bb69-49db-9997-1679a75bac26

Reported adverse events (FAERS/openFDA)#

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