Label: MYNTSMILE DIAMYNT- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 42357-001-01 - Packager: LMKAO LLC
- Category: HUMAN OTC DRUG LABEL
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 10, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing.
Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Glycerin, Hydrated Silica, Sorbitol, Xanthan Gum, Titanium Dioxide, Flavor, Cocamidopropyl Betaine, Xylitol, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extarct, Diamond Powder
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MYNTSMILE DIAMYNT
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42357-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.83 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XYLITOL (UNII: VCQ006KQ1E) ALOE VERA LEAF (UNII: ZY81Z83H0X) MENTHA PIPERITA (UNII: 79M2M2UDA9) SAGE (UNII: 065C5D077J) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) DIAMOND (UNII: 6GRV67N0U2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42357-001-01 1 in 1 BOX 1 112 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/10/2012 Labeler - LMKAO LLC (078346159)