OTC - ACTIVE INGREDIENT SECTION
Mouthwash
Active ingredients
Sodium fluoride 0.05% (0.02% W/V fluoride ion) Purpose Anticavity
VVARDIS SET STRONG MINT
- Manufacturer
- Swiss Shine Beauty AG | System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH | Marvinpac SA
- Effective date
- 2021-08-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:41:59
Label at a glance#
ProductVVARDIS SET STRONG MINT
Active ingredientSODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Toothpaste
Active Ingredients
Sodium monofluorophosphate 0.88% (0.115% W/V flouride ion) Purpose Anticavity
OTC - PURPOSE SECTION
Use
Aids in the prevention of dental cavities.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
INDICATIONS & USAGE SECTION
Supervise children as necessary until capable of using without supervison.
WARNINGS SECTION
Warnings Keep out of reach of children. If more than used for rinsing is accidently swallowed, get medical help or contact a Poison Control Center right away.
WARNINGS SECTION
Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Shake well before use.
Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste.
Vigorously swish 10 milliliters of 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 under 12 years of age 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.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
Supervise children as necessary until capable of using without supervison.
Children under 2 years of age: consult a dentist or doctor.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
water, glycerin, propylene glycol, xylitol, peg-40 hydrogenated castor oil, flavor, sodium citrate, zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide
INACTIVE INGREDIENT SECTION
Inactive Ingredients water, hydrated silica, sorbitol, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, xanthan gum, calcium carbonate, citric acid, flavor, zinc lactate, menthol, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
VVardis Set Strong Mint
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | 2 |
| 1546238 | sodium monofluorophosphate 0.88 % Toothpaste | PSN | 2 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | 2 |
| 1546238 | sodium monofluorophosphate 0.0088 MG/MG Toothpaste | SCD | 2 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | 2 |
| 1546238 | sodium monofluorophosphate 0.88 % (fluoride ion 0.115 % )Toothpaste | SY | 2 |
| 1546238 | sodium monofluorophosphate 0.88 % Toothpaste | SY | 2 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 79763-008-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1185-0266-e053-dadaa90a7c1a | VVARDIS SET STRONG MINT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 79763-008-01 | VVARDIS SET STRONG MINT | 1 in 1 KIT | KIT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- VVARDIS SET STRONG MINT
- Sodium monofluorophosphate, Sodium fluoride
- Pure Whitening Fluoride Mouthwash Strong Mint
- Sodium Fluoride
- FLUORIDE ION
- POLYOXYL 40 HYDROGENATED CASTOR OIL
- POLOXAMER 407
- XYLITOL
- WATER
- GLYCERIN
- HYDROCHLORIC ACID
- CHLORHEXIDINE GLUCONATE
- PROPYLENE GLYCOL
- CITRIC ACID MONOHYDRATE
- SODIUM HYDROXIDE
- ZINC LACTATE
- SODIUM CITRATE
- Fluoride Strong Mint
- Sodium monofluorophosphate
- SODIUM COCO-SULFATE
- MENTHOL, UNSPECIFIED FORM
- POTASSIUM SORBATE
- CALCIUM CARBONATE
- RHODODENDRON FERRUGINEUM WHOLE
- LEONTOPODIUM ALPINUM FLOWERING TOP
- TRIBASIC CALCIUM PHOSPHATE
- HYDRATED SILICA
- XANTHAN GUM
- SODIUM BENZOATE
- SORBITOL
- Instant Bright and White concentrate for teeth
- MANNITOL
- PENTYLENE GLYCOL
- POLYETHYLENE GLYCOL 400
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79763-008 | 79763-008-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| c9ee4590-eca7-3188-e053-2a95a90afbc2 | b1aa063c-cf71-487b-e053-2995a90af818 | 2021-08-19 | Warnings | c9ee4590-eca7-3188-e053-2a95a90afbc2 b1aa063c-cf71-487b-e053-2995a90af818 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.