BURKHART- stannous fluoride gel

Burkhart by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient:

Stannous Fluoride 0.4%

Purpose:

Fluoride preventive treatment gel.

Uses:

• Home Care is a stable, water-free fluoride gel for home use.
• Aids in the prevention of dental decay.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Warnings:

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
• This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Directions:

Adults and children 6 years of age and older: Twist off cap and remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. 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.

Other Information:

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

Inactive Ingredients:

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURKHART 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43498-250
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.116 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
Malic Acid (UNII: 817L1N4CKP)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	white (Cloudy)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43498-250-04	120 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/05/2013

Labeler - Burkhart Dental Supply Inc (027532357)