Indications and uses
Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity
Aids in the prevention of dental caries (cavities). Control of perio infection Relief of dentin sensitivity
Do not use before mixing with water Use immediately after preparing the rinse Adults and children 6 years of age and older: Use as directed by a dental professional Use once a day after brushing your teeth with a toothpaste or as directed by your dentist Remove cap and seal and replace with pump Rotate spout counter clockwise to extend Depress pump until medicine comes to the tip of the pump Put 1/8 oz. (approx. 2...
Drug Facts
Stannous Fluoride 0.63% w/w
(0.19% w/v fluoride ion)
anticavity
When using this product it 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.
Keep out of reach of children. If more than used for rinsing s accidentally swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 6 years of age and older:
Children 6 to 12 years of age:
Children under 6 years of age:
For your protection, do not use if seal under the cap is broken or missing.
flavor, glycerin, methylparaben, propylparaben, sodium saccharin
NDC 59883-720-08
pro-denRx ®
dye
free
rinse
0.63 % stannous fluoride
mint
flavor
IMPORTANT:
Read directions for proper use.
10 fl. oz.
(283.5 g)
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59883-720-08 | Pro-Den Rx | 283.5 g in 1 BOTTLE | RINSE | 283.5 | 6 | |
| 59883-720-08 | Pro-Den Rx | 1 in 1 CARTON | RINSE | 1 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| STANNOUS FLUORIDE | ACTIVE INGREDIENT | 3FTR44B32Q | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59883-720 | 59883-720-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| STANNOUS FLUORIDE | 3FTR44B32Q | 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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 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 |
|---|---|---|---|---|---|---|
| Pro-Den Rx | STANNOUS FLUORIDE | Den-mat Holdings, Llc | 9036aa8a-59b1-41b0-b3cb-529d3303a1c0 | 2023-11-20 | Warnings | 59883-720-08 59883-720 59883072008 0a95fcbe-e811-031d-e063-6294a90aec1b 9036aa8a-59b1-41b0-b3cb-529d3303a1c0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.