Label: BURKHART- stannous fluoride gel
- NDC Code(s): 43498-250-04
- Packager: Burkhart Dental Supply Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Uses:
- KEEP OUT OF REACH OF CHILDREN
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Warnings:
- If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
- This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
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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:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURKHART
stannous fluoride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43498-250 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.116 g in 120 g Inactive Ingredients Ingredient Name Strength 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 Color white (Cloudy) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43498-250-04 120 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/05/2013 Labeler - Burkhart Dental Supply Inc (027532357)
