BURKHART- sodium fluoride gel 
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:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Fluoride Treatment Gel

Indications and Usage:

Warnings:

Dosage and Administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

Store at controlled room temperature 59° to 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients:

Citric Acid, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

LB.Burkhart APF Gel_Mango Smoothie.jpg

BURKHART 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43498-108
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5.6 g  in 454 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorMANGO (Mango Smoothie) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43498-108-15454 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 other12/14/2012
Labeler - Burkhart Dental Supply Inc (027532357)

Revised: 2/2022
Document Id: d70dee10-cc1c-4db1-e053-2995a90a5c50
Set id: 804e7850-1952-4e86-804e-d800ee6e7b50
Version: 4
Effective Time: 20220202
 
Burkhart Dental Supply Inc