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Product NDC Code | 61041-212 | ||||||
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Drug Name | Xerostom |
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Type | Brand | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | PASTE | ||||||
RxCUI drug identifier | 245598 | ||||||
Application Number | part355 | ||||||
Labeler Name | Bio Cosmetics S L | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Sodium Fluoride 0.22%
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.Dosage and administration Adults and children over 12 years apply toothpaste onto a soft bristle toothbrush brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Glycerin Water Hydrated Silica Xylitol Betaine Tetrapotassium Pyrophosphate Olive Oil Xanthan Gum Titanium Dioxide Potassium Phosphate Flavor Diazolidinyl Urea Papain, Parsley Oil D-Panthenol Tocopheryl Acetate.
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.Indications & Usage Section Aids in the prevention of dental cavities.
Purpose
Information about the drug product’s indications for use.Purpose Section Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.XEROSTOM SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION GLYCERIN WATER HYDRATED SILICA XYLITOL BETAINE POTASSIUM PYROPHOSPHATE OLIVE OIL XANTHAN GUM TITANIUM DIOXIDE POTASSIUM PHOSPHATE, UNSPECIFIED FORM DIAZOLIDINYL UREA PAPAIN PARSLEY OIL DEXPANTHENOL .ALPHA.-TOCOPHEROL ACETATE
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 image description
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 12yrs of age and under
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 12 years of age and under. For external use only. If you accidentally swallow more than used for brushing, get medical help or contact a Poisson Control Center immediately. Do not use if you are allergic to any of the ingredients.
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