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Burkhart

Burkhart Dental Supply Inc


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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.

Burkhart

Burkhart

Burkhart

Stannous Fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43498-251
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 0.116 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
CARBOXYMETHYLCELLULOSE SODIUM
Malic Acid
XANTHAN GUM

Product Characteristics

Color
white (Cloudy)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43498-251-04 120 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2013-01-05


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