SEAVUE ANTI-CARIES GEL- sodium fluoride gel

Seavue Anti-caries Gel by

Drug Labeling and Warnings

Seavue Anti-caries Gel by is a Otc medication manufactured, distributed, or labeled by Xiling (Zhenjiang) Medical Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride

ASK DOCTOR

Do not use in children under 6 years of age unless directed by a dentist or physician.

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

PURPOSE

Anticavity

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEAVUE ANTI-CARIES GEL 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87118-004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.36 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
POTASSIUM NITRATE (UNII: RU45X2JN0Z)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87118-004-01	1 g in 1 BOX; Type 0: Not a Combination Product	10/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/08/2025

Labeler - Xiling (Zhenjiang) Medical Technology Co., Ltd. (707119039)