Label: BURKHART- stannous fluoride concentrate
- NDC Code(s): 43498-201-10
- Packager: Burkhart Dental Supply Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 2, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Indications and Usage:
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Warnings:
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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.
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Keep out of reach of children.
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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:
- Other Information:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURKHART
stannous fluoride concentrateProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43498-201 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 RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43498-201-10 284 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)
