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Glancure tooth - Medication Information

Product NDC Code 74724-0015
Drug Name

Glancure tooth

Type Brand
Active Ingredients
Sodium monofluorophosphate .35 g/100g
Route DENTAL
Dosage Form PASTE
Application Number part355
Labeler Name K.Boeun Pharmaceutical Co.,Ltd.
Packages
Package NDC Code Description
74724-0015-1 40 g in 1 tube (74724-0015-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Sodium monofluorophosphate

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.
For dental use only

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Silicon Dioxide, D-Sorbitol Solution, Water, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthan ?Gum, Peppermint Oil, Flavor, Enzymatically Modified Stevia, Citrus Paradisi (Grapefruit) Seed Extract, Raspberry Extract, Xylitol, L-Menthol, Red Cabbage Color, Lavender Oil, Chamomile Extract, Eucalyptus Extract

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.
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. Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Purpose

Information about the drug product’s indications for use.
for dental care

Spl product data elements

Usually a list of ingredients in a drug product.
Glancure Tooth Sodium monofluorophosphate XANTHAN GUM XYLITOL SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SILICON DIOXIDE

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.
1

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 THE CHILDREN

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.
Do not swallow. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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