Active Ingredients
Sodium fluoride 0.05% (0.02% W/V fluoride ion)
Purpose Anticavity
Sodium monofluorophosphate 0.88% (0.115% W/V flouride ion)
Purpose Anticavity
Vvardis Set Soft Mint
FDA Label NDC 79763-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Swiss Shine Beauty Ag for the product Vvardis Set Soft Mint (NDC 79763-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, use, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
Warnings 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.
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.
Indications & Usage
Supervise children as necessary until capable of using without supervison.
Children under 2 years of age: Consult a dentist or doctor.
Supervise children as necessary until capable of using without supervision.
Children under 6 years of age: Consult a dentist or doctor.
Warnings
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 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
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 wihtout supervision.
- Children under 6 years of age: Consult a dentist or doctor.
- 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.
Directions
Inactive Ingredients
water, glycerine, propylene glycol, xylitol, peg-40 hydrogenated castor oil, sodium citrate, flavor, zinc lactate, poloxamer 407, chlorhexidine digluconate, citric acid, hydrochloric acid, oligopeptide-104, sodium hydroxide
water, hydrated silica, hydrogenated starch hydrolysate, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, calcium carbonate, flavor, xanthan gum, citric acid, potassium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104, lactic acid.
Other Information
You may report serious side effects to: Swiss Shine Beauty, Inc
651 N. Broad St., Middletown, DE 19709
Tamper evident: Do not use if safety seal is broken or missing.
Package Label.Principal Display Panel
WEISSBAD
FRESH AND PROTECT
PURE WHITENING
FLUORIDE MOUTHWASH
SOFT MINT
100 ml e /3.4 FL OZ
EDELWEISS
WHITE AND PROTECT
FLUORIDE TOOTHPASTE
SOFT MINT
NET WT 2.3 OZ (65 g)
* Please review the disclaimer below.
