Label: HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice
HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 55882-6100-1, 55882-6100-2, 55882-6101-1, 55882-6101-2
- Packager: Hello Products LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated February 8, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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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 physician
- children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
- children under 2 years: ask a dentist or physician
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 g Tube Label
- PRINCIPAL DISPLAY PANEL - 113 g Tube Label
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INGREDIENTS AND APPEARANCE
HELLO NATURALLY WHITENING
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6100 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) CALCIUM CARBONATE (UNII: H0G9379FGK) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COCONUT OIL (UNII: Q9L0O73W7L) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) TEA TREE OIL (UNII: VIF565UC2G) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55882-6100-1 1 in 1 BOX 10/05/2018 10/31/2024 1 133 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:55882-6100-2 28 g in 1 TUBE; Type 0: Not a Combination Product 10/05/2018 10/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 10/05/2018 10/31/2024 HELLO ACTIVATED CHARCOAL
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6101 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COCONUT OIL (UNII: Q9L0O73W7L) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Product Characteristics Color BLACK Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55882-6101-1 1 in 1 BOX 10/05/2018 03/10/2023 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:55882-6101-2 28 g in 1 TUBE; Type 0: Not a Combination Product 10/05/2018 03/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 10/05/2018 03/10/2023 Labeler - Hello Products LLC (040714890)