BURKHART NEUTRAL PH- sodium fluoride gel

Burkhart Neutral pH by

Drug Labeling and Warnings

Burkhart Neutral pH by is a Prescription medication manufactured, distributed, or labeled by Burkhart Dental Supply Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Sodium Fluoride 2%

Purpose:

Fluoride Treatment Gel

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.

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 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.

Other Information:

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

Protect from freezing.

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURKHART NEUTRAL PH 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43498-150
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	4.086 g  in 454 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Phosphoric Acid (UNII: E4GA8884NN)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)
Xylitol (UNII: VCQ006KQ1E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43498-150-15	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/14/2012

Labeler - Burkhart Dental Supply Inc (027532357)