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Xerostom - Medication Information

Product NDC Code 61041-211
Drug Name

Xerostom

Type Brand
Active Ingredients
Sodium fluoride .559 mg/ml
Route ORAL
Dosage Form MOUTHWASH
Application Number part355
Labeler Name Bio Cosmetics
Packages
Package NDC Code Description
61041-211-09 1 bottle in 1 carton (61041-211-09) / 250 ml in 1 bottle
61041-211-31 15 ml in 1 packet (61041-211-31)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium Fluoride 0.055%

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 use at least twice a day after brushing. Pour 10 mililiters; vigorously swish 10mililiters of rinse between teeth for I minute. Then spit out.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Water Betaine Glycerin Peg-40 Hydrogenated Castor Oil Propylene Glycol Xylitol Aroma Potassium Phosphate Diazolidinyl Urea Allantoin Olive oil Sodium Methyl paraben Sodium Propyl Paraben Chlorophyll D-Panthenol Tocopheryl Acetate Sucralose Parsley Oil.

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 Rinse

Spl product data elements

Usually a list of ingredients in a drug product.
XEROSTOM SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER BETAINE GLYCERIN POLYOXYL 40 HYDROGENATED CASTOR OIL PROPYLENE GLYCOL XYLITOL POTASSIUM PHOSPHATE, UNSPECIFIED FORM DIAZOLIDINYL UREA ALLANTOIN OLIVE OIL METHYLPARABEN SODIUM PROPYLPARABEN SODIUM CHLOROPHYLL DEXPANTHENOL .ALPHA.-TOCOPHEROL ACETATE SUCRALOSE PARSLEY OIL

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 rinsing, 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