Label: THE HUMBLECO NATURAL FRESH MINT- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72299-001-00 - Packager: The Humble Company USA, Inc
- 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 May 29, 2018
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Use/Indication
- Warnings
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Directions
> adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush
- 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 information
- Contact/Questions:
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Inactive ingredients
HYDROGENATED STARCH HYDROLYSATE, AQUA, HYDRATED SILICA, LAURYL GLUCOSIDE, XANTHAN GUM, MENTHA PIPERITA OIL, SODIUM FLUORIDE, ZINC GLUCONATE, MENTHOL, STEVIA REBAUDIANA EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SALVIA TRILOBA LEAF EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, COMMIPHORA MYRRHA RESIN EXTRACT, LIMONENE, CI 77891.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
THE HUMBLECO NATURAL FRESH MINT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72299-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) XANTHAN GUM (UNII: TTV12P4NEE) PEPPERMINT OIL (UNII: AV092KU4JH) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) MENTHOL (UNII: L7T10EIP3A) ALOE VERA LEAF (UNII: ZY81Z83H0X) THREE-LOBE SAGE (UNII: 3V97D33N0K) MYRRH (UNII: JC71GJ1F3L) LIMONENE, (+)- (UNII: GFD7C86Q1W) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72299-001-00 75 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2018 Labeler - The Humble Company USA, Inc (080780354)