- Active Ingredient:
- Purpose:
- Indications and Usage:
-
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.
-
Keep out of reach of children.
-
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
- PRINCIPAL DISPLAY PANEL
-
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)