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.

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

Section 55106-9

Potassium nitrate, Sodium fluoride


Structured Label Content

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

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.

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

Section 55106-9 (55106-9)

Potassium nitrate, Sodium fluoride


Advanced Ingredient Data


Raw Label Data

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