Label: DENTAL KIT SOFT MINT- sodium monofluorophosphate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 82615-001-01, 82615-002-01 - 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 7, 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
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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTAL KIT SOFT MINT
sodium monofluorophosphate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82615-001 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82615-001-01 1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 03/07/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 6.5 g Part 2 1 Part 1 of 2 SOFT MINT FLUORIDE
sodium monofluorophosphate gelProduct Information Item Code (Source) NDC:82615-002 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 XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) XYLITOL (UNII: VCQ006KQ1E) SODIUM COCO-SULFATE (UNII: 3599J29ANH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) CALCIUM CARBONATE (UNII: H0G9379FGK) GLYCERIN (UNII: PDC6A3C0OX) RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU) LACTIC ACID (UNII: 33X04XA5AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82615-002-01 6.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/07/2022 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 03/07/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/07/2022 Labeler - vVARDIS AG (480487038)
