BURKHART (STANNOUS FLUORIDE ) CONCENTRATE [BURKHART DENTAL SUPPLY INC]

BURKHART (STANNOUS FLUORIDE ) CONCENTRATE [BURKHART DENTAL SUPPLY INC]
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NDC 43498-200-10
Set ID de19f0ea-7446-493d-b766-c678c727a1af
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Burkhart Dental Supply Inc
Generic Name
Product Class
Product Number
Application Number
  • 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

    LB.Burkhart .63 Stann Fl Rinse_mint.jpgLB.Burkhart .63 Stann Fl Rinse_mint.jpg

  • PRINCIPAL DISPLAY PANEL

    BX.Burkhart .63 Stann Fl Rinse.jpgBX.Burkhart .63 Stann Fl Rinse.jpg

  • INGREDIENTS AND APPEARANCE
    BURKHART 
    stannous fluoride concentrate
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43498-200
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.3408 g  in 284 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (heavy liquid) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43498-200-10284 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2013
    Labeler - Burkhart Dental Supply Inc (027532357)

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