Indications and uses
A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.
A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.
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...
Fluoride Ion 1.23%..............................................Flouride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid
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.
Store at controlled room temperature 59° to 86°F (15°-30°C).
Protect from freezing.
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5(tartrazine), yellow #6 as a color additive.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69745-014-15 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9325-d83d-e063-dadaa90ab31f | ccbde522-645f-42f2-952b-d047b91e7b17 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69745-014-15 | MS APF | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Magnesium Aluminum Silicate | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| Phosphoric Acid | INACTIVE INGREDIENT | E4GA8884NN | 1 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69745-014 | 69745-014-15 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
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 |
|---|---|---|---|---|---|---|
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | AEROSOL, FOAM / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | PASTE, DENTIFRICE / DENTAL | ADJ PH | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | OINTMENT / TOPICAL | ADJ PH | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAMUSCULAR | 22 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / SUBCUTANEOUS | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | CREAM / VAGINAL | 0.56 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | LOTION / TOPICAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| Magnesium Aluminum Silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg |
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 |
|---|---|---|---|---|---|---|
| d692a9a3-4201-6eec-e053-2a95a90a26e5 | ccbde522-645f-42f2-952b-d047b91e7b17 | 2022-01-27 | Warnings | d692a9a3-4201-6eec-e053-2a95a90a26e5 ccbde522-645f-42f2-952b-d047b91e7b17 |
Adverse event summaries are temporarily unavailable. Other product information remains available.