Otc - Active Ingredient
Sodium monofluorophosphate
Glancure Tooth
FDA Label NDC 74724-0015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by K.boeun Pharmaceutical Co.,ltd. for the product Glancure Tooth (NDC 74724-0015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
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
Otc - Purpose
for dental care
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
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.
Warnings
Do not swallow.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
For dental use only
Package Label.Principal Display Panel
1 (Label)
* Please review the disclaimer below.
