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| Product NDC Code | 61649-730 | ||||
|---|---|---|---|---|---|
| Drug Name | Bio spectra attitude |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL, DENTIFRICE | ||||
| RxCUI drug identifier | 891775 | ||||
| Application Number | M021 | ||||
| Labeler Name | 9055-7588 Quebec Inc. DBA Attitude | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride (0.243% w/w)
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 Do not swallow. Should be used as part of an oral health program that includes regular flossing and dental check-ups. Brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist. Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. Consult a dentist or health care professional before using with children under 2 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aqua / Water / Eau, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Mentha Piperita (Peppermint) Oil, Xanthan Gum, Citric Acid, Sodium Benzoate, Rebaudioside A, Sodium Bicarbonate, Potassium Sorbate, Limonene*, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract. *Naturally occuring in essentials oils. / Naturellement présent dans les huiles essentielles.
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 Prevents, fights and protects against cavities and tooth decay. Effective fluoride protection. Protects teeth from acid erosion. Penetrates tooth enamel to help rebuild weak spots.
Purpose
Information about the drug product’s indications for use.Purpose Anti-cavity
Spl product data elements
Usually a list of ingredients in a drug product.BIO SPECTRA ATTITUDE Sodium fluoride REBAUDIOSIDE A LIMONENE, (+/-)- SORBITOL WATER GLYCERIN HYDRATED SILICA SODIUM LAURYL SULFATE PEPPERMINT OIL XANTHAN GUM ANHYDROUS CITRIC ACID SODIUM BENZOATE SODIUM BICARBONATE CARICA PAPAYA LEAF GREEN TEA LEAF POTASSIUM SORBATE SODIUM FLUORIDE FLUORIDE ION Opaque
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.PRINCIPAL DISPLAY PANEL - 120 g Tube Label ATTITUDE ® natural care EWG VERIFIED Vegan with fluoride toothpaste FRESH BREATH Peppermint Super Leaves NPN 80104880 120 g 4.2 OZ. Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Removal of the storage conditions.
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
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. Keep out of reach of children. If swallowed, call a poison control centre or get medical help 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? +1-855-509-7225
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 Keep out of reach of children. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
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