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Product NDC Code | 69179-000 | ||||
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Drug Name | Marvelous |
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Type | Brand | ||||
Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | PASTE | ||||
RxCUI drug identifier | 416784 | ||||
Application Number | M021 | ||||
Labeler Name | Batool Pharma International, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Stannous Fluoride 0.454 % (0.14% w/v fluoride ion) Purpose Anticavity, antigingivitis Anti sensitivity toothpaste
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 Adult and children 12 yrs. of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or directed by a dentist or physician. -ASK A DENTIST Do not swallow Children under 12 yrs. of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other ingredients: Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Carrageenan, Sodium Gluconate, Xanthan Gum, Zinc, Citrate, Stannous Chloride, Sodium Saccharin, Sodium Hydroxide, Sucralose, Titanium Dioxide, Tea Tree Oil (Melaleuca Alternafolia: Antibacterial, Anti Vital, Anti Fungus, Antiseptic)
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: Aid in the preventing of dental cavities Helps prevent gingivitis Helps interfere toothpaste with harmful effects of plaque bacterias associated with gingivitis Helps control plaque bacteria that contribute to the development of gingivitis
Purpose
Information about the drug product’s indications for use.Purpose Anticavity, antigingivitis Anti sensitivity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Marvelous STANNOUS FLUORIDE ZINC CITRIC ACID MONOHYDRATE STANNOUS CHLORIDE SACCHARIN SODIUM SODIUM HYDROXIDE SUCRALOSE TITANIUM DIOXIDE TEA TREE OIL WATER SORBITOL HYDRATED SILICA SODIUM LAURYL SULFATE CARRAGEENAN SODIUM GLUCONATE XANTHAN GUM STANNOUS 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.Package Labeling: Label
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
Other information Products containing stannous fluoride may produce surface staining of the teeth adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist This toothpaste is specially formulated to help prevent staining
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask dentist or physician before use, if you have allergy or have allergic reaction to medications or ingredients in this product.
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 12 yrs. Of age. If 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.Question(s): Email us at [email protected]
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 under 12 yrs. Of age. If swallowed, get medical help or contact a poison control center right away. Ask dentist or physician before use, if you have allergy or have allergic reaction to medications or ingredients in this product.
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