BURKHART- stannous fluoride concentrate

Burkhart by

Drug Labeling and Warnings

Burkhart 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:

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Purpose:

Anticavity, antigingivitis, antihypersensitivity mouthrinse

Indications and Usage:

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.

Warnings:

• Keep out of reach of children.
  Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• Do not use until diluted.
  This product may produce surface staining of the teeth.
  Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Directions:

Adults and children 6 years of age and older:

• Do not use before mixing with water. Use immediately after preparing the rinse.
• Remove cap and replace with pump.
• Rotate spout container clockwise to extend.
• Depress pump until rinse comes to the tip of the pump.
• Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
• Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age:

• Consult a dentist or doctor.

Inactive Ingredients:

Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.

Other Information:

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURKHART 
stannous fluoride concentrate

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43498-200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.3408 g  in 284 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	white (heavy liquid)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43498-200-10	284 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		02/01/2013

Labeler - Burkhart Dental Supply Inc (027532357)