Label: FLUORIDE STRONG MINT- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 79763-007-01, 79763-007-02 - Packager: Swiss Shine Beauty AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 20, 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, 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
FLUORIDE STRONG MINT
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79763-007 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 ZINC LACTATE (UNII: 2GXR25858Y) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM COCO-SULFATE (UNII: 3599J29ANH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CALCIUM CARBONATE (UNII: H0G9379FGK) XYLITOL (UNII: VCQ006KQ1E) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) SODIUM BENZOATE (UNII: OJ245FE5EU) RHODODENDRON FERRUGINEUM WHOLE (UNII: FO6B1S7BZU) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79763-007-01 65 g in 1 TUBE; Type 0: Not a Combination Product 10/14/2020 2 NDC:79763-007-02 6.5 g in 1 TUBE; Type 0: Not a Combination Product 01/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/14/2020 Labeler - Swiss Shine Beauty AG (480422958) Establishment Name Address ID/FEI Business Operations System Kosmetik Produktionsgesellschaft fur kosmetische Erzeugnisse mbH 328825757 manufacture(79763-007) Establishment Name Address ID/FEI Business Operations Marvinpac SA 482060329 pack(79763-007)
