Otc - Active Ingredient
Active Ingredients Purpose
Sodium monofluorophosphate 0.88% (0.115% W/V fluoride Ion) Anticavity
Dental Kit Soft Mint
FDA Label NDC 82615-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vvardis Ag for the product Dental Kit Soft Mint (NDC 82615-001). 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, other safety information, inactive ingredient, 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 under 6 years age.
Indications & Usage
Use
Aids in the prevention of dental cavities.
Warnings
Keep our 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
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 supervision.
Children under 2 years of age: Consult a dentist or doctor.
Other Safety Information
Other Information
You may report serious side effects to : vVardis, Inc.
651 N. Broad St., Middletown, DE 19709
Inactive Ingredient
Inactive Ingredients
water, hydrated silica, hydrogenated strach hydrolysate, glycerin, hydroxyapatite, xylitol, sodium coco-sulfate, calcium carbonate, flavor, xanthan gum, citric acid, potasium sorbate, sodium benzoate, leontopodium alpinum flower/leaf extract, rhododendron ferrugineum extract, oligopeptide-104, lactic acid
Package Label.Principal Display Panel
vVARDIS
Switzerland
Dental Kit by VVARDIS
One Toothbrush
One Fluoride toothpaste
Soft Mint
NET. WT. 0.2 OZ (6.5g)
Dental Kit Soft (C401133 Dental Kit Us Soft Spm Print)
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