3f47f399-1a14-5264-e063-6394a90aeb1c

SPL v1
SPL
SPL Set ID 3f47f399-1a14-5264-e063-6394a90aeb1c
Route
dental
Published
Effective Date 2025-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.36 mg) nitrate ion (26 mg)

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
otc monograph drug active Since 2025-10-08

Description

Potassium nitrate, Sodium fluoride


Medication Information

Warnings and Precautions

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.

Active Ingredient

Potassium nitrate, Sodium fluoride

Indications and 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.

Dosage and 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

Description

Potassium nitrate, Sodium fluoride

Section 50565-1

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.

Section 50567-7

Use once or twice daily as needed.

Section 50569-3

Stop use and ask a doctor if irritation, swelling, or allergic reaction occurs.

Section 50570-1

Do not use in children under 12 years of age unless recommended by a dentist or physician

Section 51727-6

None

Section 51945-4

Section 55105-1

Oral antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

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.

Active Ingredient (55106-9)

Potassium nitrate, Sodium fluoride

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

Use once or twice daily as needed.

Section 50569-3 (50569-3)

Stop use and ask a doctor if irritation, swelling, or allergic reaction occurs.

Section 50570-1 (50570-1)

Do not use in children under 12 years of age unless recommended by a dentist or physician

Section 51727-6 (51727-6)

None

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Oral antiseptic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)