Label: BEYOND ACTIVATED COCONUT CHARCOAL AND SEA SALT- sodium fluoride paste, dentifrice
- NDC Code(s): 42199-008-04
- Packager: Beyond International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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 or rinsing habits (to minimize swallowing)
- supervise children as necessary until good habits are established
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children under 2 years: ask a dentist or doctor
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INACTIVE INGREDIENT
Inactive ingredients Sorbitol, Silica, Water (Aqua), Propylene Glycol, Activated Charcoal, PEG-1450, Sodium Lauryl Sulfate, PEG-400, Cellulose Gum, Sodium Hydroxide, Hydroxyethylellulose, Sea Salt, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Calcium Peroxide, Polyvinyl Alcohol, Ethylcellulose, Glycerin, Grape (Vitis Vinifera) Seed Oil, Eugenol, Flavor, Titanium Dioxide
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INGREDIENTS AND APPEARANCE
BEYOND ACTIVATED COCONUT CHARCOAL AND SEA SALT
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42199-008 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.24 g in 100 g Inactive Ingredients Ingredient Name Strength CALCIUM PEROXIDE (UNII: 7FRO2ENO91) GRAPE SEED OIL (UNII: 930MLC8XGG) EUGENOL (UNII: 3T8H1794QW) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SEA SALT (UNII: 87GE52P74G) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42199-008-04 1 in 1 CARTON 11/10/2021 11/15/2026 1 130 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 11/10/2021 11/15/2026 Labeler - Beyond International Inc (080721790) Establishment Name Address ID/FEI Business Operations Beyond International Inc 080721790 manufacture(42199-008)
