Indications and uses
Home Care is a stable, water-free fluoride gel for home use. Aids in the prevention of dental decay.
Burkhart
- Manufacturer
- Burkhart Dental Supply Inc
- Effective date
- 2025-01-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:44
Label at a glance#
ProductBurkhart
Active ingredientSTANNOUS FLUORIDE
Label structure9 sections
Dosage and administration
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 ...
Storage and handling
Store at controlled room temperature 59° - 86°F (15° - 30°C)
Label contents#
Full prescribing information#
Active Ingredient:
Stannous Fluoride 0.4%
Purpose:
Fluoride preventive treatment gel.
Uses:
- Home Care is a stable, water-free fluoride gel for home use.
- Aids in the prevention of dental decay.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
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.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43498-250-04 | Burkhart | 120 g in 1 TUBE | GEL | 120 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Stannous Fluoride | ACTIVE INGREDIENT | 3FTR44B32Q | 1 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Malic Acid | INACTIVE INGREDIENT | 817L1N4CKP | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Burkhart
- Stannous Fluoride
- GLYCERIN
- WATER
- CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
- CARBOXYMETHYLCELLULOSE SODIUM
- MALIC ACID
- XANTHAN GUM
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43498-250 | 43498-250-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| MALIC ACID | 817L1N4CKP | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| STANNOUS FLUORIDE | 3FTR44B32Q | ACTIM |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TOPICAL | 85 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TOPICAL | 85 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SUSPENSION / ORAL | 1392 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SUSPENSION / ORAL | 1392 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | SOLUTION / ORAL | 16760 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | SUSPENSION / ORAL | 180 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | SUSPENSION / ORAL | 180 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | SOLUTION / ORAL | 16760 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SOLUTION / ORAL | 1230 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | TABLET / ORAL | 20 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SOLUTION / ORAL | 1230 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | TABLET / ORAL | 20 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Burkhart | STANNOUS FLUORIDE | Burkhart Dental Supply Inc | 048c9978-e32e-4f77-9a4e-40acd5fcdfaf | 2025-01-09 | Warnings | 43498-250-04 43498-250 43498025004 2b483c18-3a2d-1701-e063-6294a90a3f49 048c9978-e32e-4f77-9a4e-40acd5fcdfaf |