Label: DENTAL KIT STRONG MINT- sodium monofluorophosphate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 82615-003-01, 82615-004-01 - Packager: vVardis AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTAL KIT STRONG MINT
sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82615-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82615-003-01 1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 03/04/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 8.5 g Part 2 1 Part 1 of 2 SRONG MINT FLUORIDE
sodium monofluorophosphate gelProduct Information Item Code (Source) NDC:82615-004 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.88 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU) XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SODIUM COCO-SULFATE (UNII: 3599J29ANH) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) ZINC LACTATE (UNII: 2GXR25858Y) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) CALCIUM CARBONATE (UNII: H0G9379FGK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82615-004-01 6.5 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/05/2022 Part 2 of 2 TOOTHBRUSH
toothbrush, manual not applicableProduct Information Route of Administration DENTAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Exempt device EFW 03/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/04/2022 Labeler - vVardis AG (480487038)
