BURKHART- stannous fluoride concentrate 
Burkhart Dental Supply Inc

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.

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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:

Directions:

Adults and children 6 years of age and older:

Children under 6 years of age:

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.

LB.Burkhart .63 Stann Fl Rinse_mint.jpgBX.Burkhart .63 Stann Fl Rinse.jpg

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)

Revised: 2/2022
Document Id: d70dcc83-25ca-3eb9-e053-2a95a90a5c02
Set id: de19f0ea-7446-493d-b766-c678c727a1af
Version: 3
Effective Time: 20220202
 
Burkhart Dental Supply Inc