MedPath

Burkhart

Approved
Approval ID

804e7850-1952-4e86-804e-d800ee6e7b50

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 2, 2022

Manufacturers
FDA

Burkhart Dental Supply Inc

DUNS: 027532357

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43498-108
Product Classification
G
Generic Name
Sodium Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateFebruary 2, 2022
FDA Product Classification

INGREDIENTS (13)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 5.6 g in 454 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/22/2017

LB.Burkhart APF Gel_Mango Smoothie.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/12/2013

Indications and Usage:

  • 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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 12/12/2013

Purpose:

Fluoride Treatment Gel

WARNINGS SECTION

LOINC: 34071-1Updated: 12/12/2013

Warnings:

  • 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 & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/12/2013

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% effectiveness).

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/22/2017

Other Information:

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

Protect from freezing.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/12/2013

Inactive Ingredients:

Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

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Burkhart - FDA Drug Approval Details