Otc - Active Ingredient
Potassium nitrate, Sodium fluoride
Seavue Dental Desensitizer Gel, Dentifrice
FDA Label NDC 87118-003
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 Dental Desensitizer (NDC 87118-003). 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
Stop use and ask a doctor if irritation, swelling, or allergic reaction occurs.
Otc - Do Not Use
Do not use in children under 12 years of age unless recommended by a dentist or physician
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than used for treatment is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Otc - Purpose
Oral antiseptic
Otc - When Using
Use once or twice daily as needed.
Dosage & Administration
Dosage:
Potassium nitrate 2.6% ................................................ Tooth desensitizer
Sodium fluoride 0.3% (0.14% w/v fluoride ion) ............ Anticavity
Use:
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Aids in the prevention of dental cavities
Warnings
Do not use in children under 12 years of age unless recommended by a dentist or physician
Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.
Keep out of reach of children. If more than used for treatment is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Patients with gingival ulcers, stomatitis, or oral mucosal ulcers should use with caution.
Inactive Ingredient
None
Indications & Usage
Adults and children 12 years and older:
Apply the product using one of the following methods:
Apply evenly on a mouthguard, wear for 15–30 minutes, then remove and rinse.
Or apply directly to sensitive teeth using a cotton swab or soft brush. Rub gently, leave for 2–3 minutes, rinse and spit out.
Use once or twice daily as needed.
Children under 12 years: ask a dentist.
Package Label.Principal Display Panel
123 (0033)
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