Otc - Active Ingredient
Active Ingredients Purpose
sodium monofluorophosphate 0.88%
(0.115% W/W fluoride Ion) Anticavity
Dental Kit Strong Mint
FDA Label NDC 82615-003
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 Strong Mint (NDC 82615-003). 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 under 6 years of age.
Indications & Usage
If more than used for brushing 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.
Dosage & Administration
- Adults and children 2 years of age and older:Brush teeth thoroughly, preferable 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
Inactive Ingredient
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
Switzerland
Dental Kit by VVARDIS
One Toothbrush
One Fluoride toothpaste
Strong Mint
NET. WT. 0.2 OZ (6.5g)
Dental Kit Strong Mint (C401134 Dental Kit Us Strong Spm Print)
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