FDA Label for Seavue Anti-caries Gel
View Indications, Usage & Precautions
Seavue Anti-caries Gel Product Label
The following document was submitted to the FDA by the labeler of this product Xiling (zhenjiang) Medical Technology Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Sodium Fluoride
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
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