Indications and uses
aids in the prevention of childhood dental decay helps prevent gingivitis helps control plaque bacteria builds increasing protection against painful tooth sensitivity
PerioMed
- Manufacturer
- Solventum US LLC
- Effective date
- 2024-08-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 00:16:49
Label at a glance#
ProductPerioMed
Active ingredientStannous Fluoride
Label structure11 sections
Dosage and administration
adults and children 6 years of age and older: do not use before mixing with water use immediately after preparing the rinse 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...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Stannous fluoride 0.63% w/w (0.19% w/v flouride ion)
Purpose
anticavity, antigingivitis, antihypersensitivity, mouthrinse
Uses
- aids in the prevention of childhood dental decay
- helps prevent gingivitis
- helps control plaque bacteria
- builds increasing protection against painful tooth sensitivity
Warnings
OTC - WHEN USING SECTION
- When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
OTC - STOP USE SECTION
- Stop use and ask a doctor if sensitivity persists or worsens.
- Sensitive teeth may indicate a serious problem that may need prompt care.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 6 years of age and older:
- do not use before mixing with water
- use immediately after preparing the rinse
- 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 pump strokes) of concentrated PerioMed Rinse into the provided mixing vial
- add water to 1 oz. line on mixing vial
- tightly snap on the cap and shake well
- vigorously swish rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children in good rinsing habits (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
- For professional use only
- products containing stannous fluoride may produce surface staining of the teeth
- adequate toothbrushing may prevent these stains which are not harmful and may be removed by your dentist
- see your dentist regularly
- this product is not intended for home or unsupervised consumer use
- for your protection, do not use if seal under the cap is broken or missing
Inactive ingredients
flavor, glycerin, methyl paraben, propyl paraben, sodium saccharin
Questions or comments?
1-800-634-2249
Principal Display Panel – Box Label (Mint – 283.5 g)
NDC 48878-3315-0
Mint
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
Principal Display Panel – Box Label (Mint – 78 g)
NDC 48878-3315-2
Mint
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 2.75 oz (78g)
Principal Display Panel – Box Label (Tropical Fruit – 283.5 g)
NDC 48878-3317-0
Tropical Fruit
3M ESPE
PerioMed™
0.63% Stannous
Fluoride Concentrate
Antimicrobial
Oral Rinse
Non-Alcohol
Formula
IMPORTANT: Read
directions carefully
before using.
Contents:
1 Bottle
NET WT. 10 oz (283.5g)
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48878-3315-0 | PerioMed | 283.5 g in 1 BOTTLE, PLASTIC | RINSE | 283.5 | 9 | |
| 48878-3315-0 | PerioMed | 1 in 1 BOX | RINSE | 1 | 9 | |
| 48878-3315-2 | PerioMed | 85 g in 1 BOTTLE, PLASTIC | RINSE | 85 | 9 | |
| 48878-3315-2 | PerioMed | 1 in 1 BOX | RINSE | 1 | 9 | |
| 48878-3317-0 | PerioMed | 1 in 1 BOX | RINSE | 1 | 9 | |
| 48878-3317-0 | PerioMed | 283.5 g in 1 BOTTLE, PLASTIC | RINSE | 283.5 | 9 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48878-3315 | PERIOMED (STANNOUS FLUORIDE) RINSE [SOLVENTUM US LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240808_7f79eb00-86df-4284-b415-47f45e4849da.zip |
| 48878-3317 | PERIOMED (STANNOUS FLUORIDE) RINSE [SOLVENTUM US LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240808_7f79eb00-86df-4284-b415-47f45e4849da.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48878-3315-0 | GM - Gram | 48878-3315 | 6a3c1634-849e-4d9d-86f5-6fa8151b070a | 1 | 2012-07-24 |
| 48878-3315-2 | GM - Gram | 48878-3315 | 89896d02-6fae-4885-b1c3-1890d66ac068 | 1 | 2024-04-05 |
| 48878-3317-0 | GM - Gram | 48878-3317 | 62347bd9-48ff-4d03-a247-e6bc68c57b5d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| stannous fluoride | ACTIVE INGREDIENT | 3FTR44B32Q | 1 | |
| fluoride ion | ACTIVE MOIETY | Q80VPU408O | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 |
Products#
Every source-derived product name is available through these pages.
- PerioMed
- Stannous Fluoride
- Fluoride Ion
- Glycerin
- Methylparaben
- Propylparaben
- Saccharin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48878-3315 | 48878-3315-0, 48878-3315-2 |
| 48878-3317 | 48878-3317-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Stannous Fluoride | 3FTR44B32Q | ACTIM |
| Glycerin | PDC6A3C0OX | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Saccharin | FST467XS7D | IACT |
| Stannous Fluoride | 3FTR44B32Q | ACTIM |
| Glycerin | PDC6A3C0OX | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Saccharin | FST467XS7D | IACT |
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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 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 |
|---|---|---|---|---|---|---|
| PerioMed | STANNOUS FLUORIDE | Solventum US LLC | 7f79eb00-86df-4284-b415-47f45e4849da | 2024-08-01 | Warnings | 48878-3315-2 48878-3317-0 48878-3315-0 48878-3315 48878-3317 48878331700 48878331502 48878331500 928be263-9602-4672-b460-8f840da667b9 7f79eb00-86df-4284-b415-47f45e4849da |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.