Label: FLUORIDE SOFT MINT- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 79763-003-01, 79763-003-02 - Packager: Swiss Shine Beauty 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 August 19, 2021
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.
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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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLUORIDE SOFT MINT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79763-003 Route of Administration ORAL 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 POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) XYLITOL (UNII: VCQ006KQ1E) SODIUM COCO-SULFATE (UNII: 3599J29ANH) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LACTIC ACID (UNII: 33X04XA5AT) CALCIUM CARBONATE (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) HYDRATED SILICA (UNII: Y6O7T4G8P9) RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79763-003-01 65 g in 1 TUBE; Type 0: Not a Combination Product 07/22/2020 2 NDC:79763-003-02 6.5 g in 1 TUBE; Type 0: Not a Combination Product 07/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/22/2020 Labeler - Swiss Shine Beauty AG (480422958) Establishment Name Address ID/FEI Business Operations System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH 328825757 manufacture(79763-003) Establishment Name Address ID/FEI Business Operations Marvinpac SA 482060329 pack(79763-003)
