1. Use after thorough prophylaxis. 2. Shake prior to dispensing. 3. Place nozzle tip to applicator floor and press down on trigger to dispense foam. NOTE: Foam will expand to fill tray. 4. Immediately place trays in mouth and have patient bite down lightly for one minute. 5. Remove trays and have patient expectorate excess.
A topical anticaries preparation for professional dental use only.
1.23% fluoride ion (from 1.69% sodium fluoride and 0.5% hydrogen fluoride) in a flavored base at pH 4.
1.23% fluoride ion.
Water, glycerin, cocamidopropyl betaine, xylitol, phosphoric acid, flavouring agents, xanthan gum, polysorbate 20, poloxamer 407, sodium saccharin, PVP, sodium benzoate
1. Use after thorough prophylaxis. 2. Shake prior to dispensing. 3. Place nozzle tip to applicator floor and press down on trigger to dispense foam. NOTE: Foam will expand to fill tray. 4. Immediately place trays in mouth and have patient bite down lightly for one minute. 5. Remove trays and have patient expectorate excess.
Do not eat, drink, or rinse for 30 minutes after treatment. Do not puncture or incinerate container or store at temperatures over 50°C. Do not use in presence of open flame or spark. Contents under pressure; do not place in hot water or near any sources of heat.
Kep out of reach of children.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61508-1120-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5626-f424-e053-dadaa90a57ce | 47a4940b-5f6a-2624-e054-00144ff8d46c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61508-1120-1 | Floam Topical Floam Fluoride | 125 g in 1 BOTTLE, PLASTIC | AEROSOL, FOAM | 125 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61508-1120 | FLOAM TOPICAL FLOAM FLUORIDE (SODIUM FLUORIDE) AEROSOL, FOAM [GERMIPHENE CORPORATION] | 2 | Legacy NDC, 1 package rows | 20170517_47a4940b-5f6a-2624-e054-00144ff8d46c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61508-1120 | 61508-1120-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROFLUORIC ACID | RGL5YE86CZ | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | IACT |
| WATER | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|
| 4fb91ca4-deaa-4dc6-e054-00144ff88e88 | 47a4940b-5f6a-2624-e054-00144ff8d46c | 2017-05-17 | Warnings | 4fb91ca4-deaa-4dc6-e054-00144ff88e88 47a4940b-5f6a-2624-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.