MedActive Patient Friendly
- Manufacturer
- Integrate Oral Care, LLC.
- Effective date
- 2021-12-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-05-31 23:46:05
Label at a glance#
ProductMedActive Patient Friendly
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections
Contacts and useful links#
Websitewww.medactive.com
www.medactive.com
www.medactive.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Stannous fluoride 0.1%
OTC - PURPOSE SECTION
Purpose
Cavity protection
INDICATIONS & USAGE SECTION
Uses
- Aids in the prevention of dental decay.
WARNINGS SECTION
Warnings
- When using this product, do not use longer than four weeks unless recommended by a medical doctor and/or dental professional.
- If more than used for rinsing is swallowed, seek medical attention or contact a Poison Control Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
Use immediately after preparing the rinse as follows:
Adults and children 6 years of age and older:
- Place both thumbs on Blue Chamber No. 1 and Press down firmly to squeeze fluoride into Chamber No. 2.
- Gently Shake.
- Snap Tab to Open by bending at line on the cap. Dispense half of mixture into the mouth and Rinse for 30 seconds. Spit.
- Gargle with remainder of mixture for 30 seconds. Spit.
- Avoid any food or drinks for at least 15 minutes after use.
Children under 6 years of age:
- Consult your medical doctor and/or dental professional
OTHER SAFETY INFORMATION
Other information
- This product 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 dental professional.
- Do not refrigerate. Store at room temperature.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilathes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water
OTC - QUESTIONS SECTION
Questions or comments?
1-866-877-4867 M-F 9am-5pm EST or
www.medactive.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Patient-Friendly™ Ruby Raspberry
Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract
10 DOSE PACKS
IMPORTANT Read directions for proper use.
NET CONTENTS: 10 DOSE PACKS 10.4 FL OX (307 mL)
NDC 49741-1007-2
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Patient-Friendly™ Ruby Raspberry
Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract
30 DOSE PACKS
IMPORTANT: Read directions for proper use.
NDC 49741-1007-3
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1654969 | MedActive Oral Relief Rinse 0.1 % Oral Rinse | PSN | 12 |
| 1654967 | stannous fluoride 0.1 % Oral Rinse | PSN | 12 |
| 583459 | stannous fluoride 0.63 % Dental Solution | PSN | 12 |
| 1654969 | stannous fluoride 1 MG/ML Mouthwash [MedActive Rinse] | SBD | 12 |
| 1654967 | stannous fluoride 1 MG/ML Mouthwash | SCD | 12 |
| 583459 | stannous fluoride 6.3 MG/ML Mouthwash | SCD | 12 |
| 1654969 | MedActive Oral Relief Rinse 0.1 % Mouthwash | SY | 12 |
| 1654969 | MedActive Rinse 1 MG/ML Mouthwash | SY | 12 |
| 583459 | stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution | SY | 12 |
| 583459 | stannous fluoride 0.63 % Dental Solution | SY | 12 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49741-1007-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1aff-0266-e053-dadaa90a7c1a | 18cc93a4-0ddf-1fa9-e054-00144ff88e88 |
| 49741-1007-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1aff-0266-e053-dadaa90a7c1a | 18cc93a4-0ddf-1fa9-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49741-1007-1 | MedActive Patient Friendly | 1 in 1 CARTON | KIT | 1 | 12 | |
| 49741-1007-2 | MedActive Patient Friendly | 10 in 1 BOX | KIT | 10 | 12 | |
| 49741-1007-3 | MedActive Patient Friendly | 1 in 1 CARTON | KIT | 1 | 12 | |
| 49741-1007-3 | MedActive Patient Friendly | 30 in 1 BOX | KIT | 30 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49741-1007 | MEDACTIVE PATIENT FRIENDLY (STANNOUS FLUORIDE) KIT [INTEGRATE ORAL CARE, LLC.] | 12 | Legacy NDC, 4 package rows | 20211231_18cc93a4-0ddf-1fa9-e054-00144ff88e88.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| STANNOUS FLUORIDE | ACTIVE INGREDIENT | 3FTR44B32Q | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETIC ACID | INACTIVE INGREDIENT | 9G34HU7RV0 | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- MedActive Patient Friendly
- Stannous Fluoride
- Chamber No. 1
- FLUORIDE ION
- FD&C GREEN NO. 3
- GLYCERIN
- Chamber No. 2
- Stannous Fluoride Diluent
- SACCHARIN SODIUM
- SORBITOL
- DIMETHICONE
- POTASSIUM SORBATE
- POLOXAMER 407
- SUCRALOSE
- WATER
- EDETIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49741-1007 | 49741-1007-1, 49741-1007-2, 49741-1007-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STANNOUS FLUORIDE | 3FTR44B32Q | ACTIM |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| EDETIC ACID | 9G34HU7RV0 | 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 |
|---|---|---|---|---|---|---|
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | GEL / TOPICAL | 0.1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | CONCENTRATE / ORAL | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | TABLET / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | GEL / OPHTHALMIC | 1 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SHAMPOO / TOPICAL | 0.09 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GUM, CHEWING / BUCCAL | 70 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | CAPSULE, DELAYED RELEASE / ORAL | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | PASTE / ORAL | 48 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SOLUTION / TOPICAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | WAFER / ORAL | 8 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SUSPENSION / TOPICAL | 0.06 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / SUBLINGUAL | 7 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE, COATED PELLETS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 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 |
|---|---|---|---|---|---|---|
| d4646175-37dc-12f1-e053-2a95a90aab1c | 18cc93a4-0ddf-1fa9-e054-00144ff88e88 | 2021-12-30 | Warnings | d4646175-37dc-12f1-e053-2a95a90aab1c 18cc93a4-0ddf-1fa9-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.