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| Product NDC Code | 42199-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Beyond activated coconut charcoal and sea salt |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416783 | ||||
| Application Number | M021 | ||||
| Labeler Name | Beyond International Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 children under 2 years: ask a dentist or doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Aids in prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Beyond Activated Coconut Charcoal and Sea Salt Sodium fluoride CALCIUM PEROXIDE GRAPE SEED OIL EUGENOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM ANHYDROUS ETHYLCELLULOSES GLYCERIN HYDRATED SILICA WATER SORBITOL PROPYLENE GLYCOL ACTIVATED CHARCOAL POLYETHYLENE GLYCOL 400 HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) POLYETHYLENE GLYCOL 1450 SODIUM BENZOATE TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM LAURYL SULFATE SEA SALT SODIUM HYDROXIDE POLYVINYL ALCOHOL, UNSPECIFIED SODIUM FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Vegan beyond® Activated Coconut CHARCOAL & SEA SALT FLUORIDE ANTICAVITY TOOTHPASTE Deeply Whitens Fights Cavities Reduces Plaque Soothes Gums NET WT. 4.6 OZ (130g) Charcoal Sea Salt TP-FDA
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Manufactured by: BEYOND® INTERNATIONAL INC. 711 Julie Rivers Dr. Sugar Land, TX 77478 USA ©2020 BEYOND® INTERNATIONAL INC. www.beyonddent.com
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 866-695-6452
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API