Otc - Active Ingredient
Sodium Fluoride 0.02%
Olidental Gargle
FDA Label NDC 70417-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aju Pharm Co., Ltd. for the product Olidental Gargle (NDC 70417-001). 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, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, inactive ingredient, 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
Otc - Purpose
Anticavity
Indications & Usage
Aids in the prevention of dental cavities
Dosage & Administration
Adults and children 12 years of age and older:
• Use twice daily after brushing your teeth with a toothpaste
• Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Do not eat or drink for 30 minutes after rinsing
• Supervise children as necessary until capable of suing without supervisor
Children under 12 years of age: consult a dentist or doctor
Warnings
Stop use and ask a dentist if oral irritation or tooth sensitivity occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Inactive Ingredient
Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water
* Please review the disclaimer below.
