Otc - Active Ingredient
Sodium Fluoride
Seavue Anti-caries Gel
FDA Label NDC 87118-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xiling (zhenjiang) Medical Technology Co., Ltd. for the product Seavue Anti-caries Gel (NDC 87118-004). 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 - ask doctor, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - when using, dosage & administration, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Do not use in children under 6 years of age unless directed by a dentist or physician.
Otc - Do Not Use
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Otc - Purpose
Anticavity
Otc - When Using
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Dosage & Administration
Sodium fluoride 0.3% (w/w)
Aids in the prevention of dental cavities and helps strengthen tooth enamel.
Warnings
For oral use only
Keep out of reach of children under 6 years of age.
Do not use in children under 6 years of age unless directed by a dentist or physician.
Avoid contact with eyes and skin. If contact occurs, rinse thoroughly with water.
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
Inactive Ingredient
Carbomer, Glycerin, Potassium Nitrate, Triethanolamine, Purified Water
Indications & Usage
Directions
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
Package Label.Principal Display Panel
0044 (0044)
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