Otc - Active Ingredient
Mouthwash
Active ingredients
Sodium fluoride 0.05% (0.02% W/V fluoride ion) Purpose Anticavity
Toothpaste
Active Ingredients
Sodium monofluorophosphate 0.88% (0.115% W/V flouride ion) Purpose Anticavity
Vvardis Set Strong Mint
FDA Label NDC 79763-008
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 Strong Mint (NDC 79763-008). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
Aids in the prevention of dental cavities.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Supervise children as necessary until capable of using without supervison.
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 without supervision.
Children under 6 years of age: Consult a dentist or doctor.
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
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 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
Vvardis Set Strong V1 Back (200910 Vvardis Set Strong V1)
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