BURKHART- stannous fluoride gel 
Burkhart Dental Supply Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient:

Stannous Fluoride 0.4%

Purpose:

Fluoride preventive treatment gel.

Uses:

Keep out of reach of children.

Warnings:

Directions:

Adults and children 6 years of age and older: Twist off cap and remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. 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.

Other Information:

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

Inactive Ingredients:

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

BX.Burkhart .40 Stannous.jpgSC.Burkhart .40 Stannous_mint.jpg

BURKHART 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43498-250
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.116 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MALIC ACID (UNII: 817L1N4CKP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (Cloudy) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43498-250-04120 g in 1 TUBE; Type 0: Not a Combination Product09/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/05/2013
Labeler - Burkhart Dental Supply Inc (027532357)

Revised: 2/2022
Document Id: d70dee10-cc10-4db1-e053-2995a90a5c50
Set id: 048c9978-e32e-4f77-9a4e-40acd5fcdfaf
Version: 4
Effective Time: 20220202
 
Burkhart Dental Supply Inc