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%
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid
Fluoride Treatment Gel
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, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69484-051-15 | Tiger Supply Inc 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 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 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 |
|---|---|
| 69484-051 | 69484-051-15 |
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 |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| Xylitol | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| Magnesium Aluminum Silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Magnesium Aluminum Silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | GEL / TOPICAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | GEL / TOPICAL | ADJ PH | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | PASTE, DENTIFRICE / DENTAL | ADJ PH | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | PASTE, DENTIFRICE / DENTAL | ADJ PH | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| Xylitol | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 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 |
|---|---|---|---|---|---|---|
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 129ecbf8-17c8-4259-a4ca-7c0a09298bb0 | 2022-01-20 | Warnings | 69484-051-15 69484-051 69484005115 d6089b27-80a3-7076-e053-2a95a90a2efd 129ecbf8-17c8-4259-a4ca-7c0a09298bb0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.