SPL v1
SPL
SPL Set ID 54c1a27c-5936-4ee2-a419-3891d3df9745
Route
DENTAL
Published
Effective Date 2015-08-02
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg) Nitrate Ion (5 mg)
Inactive Ingredients
.alpha.-tocopherol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Edetic Acid Glycerin Sodium Hydroxide Sodium Polymetaphosphate Tricalcium Phosphate Water Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2015-08-02
Description

Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel

Indications and Usage

This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Dosage and Administration

Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician. Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush. Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician.

Warnings and Precautions

Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.

Contraindications

Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.

Adverse Reactions

To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How Supplied

4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).

Medication Information

Warnings and Precautions

Do not swallow.

Keep out of reach of children.

Read prescribing information fully before using this product. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.

Indications and Usage

This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Dosage and Administration

Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician.

Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush. Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth.

Children under 12 years of age: consult a dentist or physician.

Dosage Forms and Strengths

Gel containing 1.1% sodium fluoride and 5% potassium nitrate.

Contraindications

Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.

Adverse Reactions

To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How Supplied

4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).

Description

Ionite H Neutral Fluoride Gel is a flavored, pH neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth.

Section 42229-5

Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel

Ionite H

NDC 53045-280-04

Home Care

1.1% Neutral Fluoride Gel

with Xylitol and Vitamin E

Spearmint

Rx Only

Made in USA

Gluten Free  Dye Free

Re-order#: 56-00140

4.3 oz. (122 g)

Active Ingredients

Sodium Fluoride, 1.1%; Potassium Nitrate, 5%

How Supplied/storage

4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).

Inactive Ingredients

Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol

Structured Label Content

Section 42229-5 (42229-5)

Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel

Ionite H

NDC 53045-280-04

Home Care

1.1% Neutral Fluoride Gel

with Xylitol and Vitamin E

Spearmint

Rx Only

Made in USA

Gluten Free  Dye Free

Re-order#: 56-00140

4.3 oz. (122 g)

Description (DESCRIPTION)

Ionite H Neutral Fluoride Gel is a flavored, pH neutral 1.1% sodium fluoride, 5% potassium nitrate gel that aids in the prevention of dental decay and hleps to treat sensitive teeth.

Adverse Reactions (ADVERSE REACTIONS)

To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Contraindications (CONTRAINDICATIONS)

Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.

Active Ingredients (ACTIVE INGREDIENTS)

Sodium Fluoride, 1.1%; Potassium Nitrate, 5%

How Supplied/storage (HOW SUPPLIED/STORAGE)

4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).

Inactive Ingredients (INACTIVE INGREDIENTS)

Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol

Indications and Usage (INDICATIONS AND USAGE)

This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Warnings and Precautions (WARNINGS AND PRECAUTIONS)

Do not swallow.

Keep out of reach of children.

Read prescribing information fully before using this product. If product is accidentially swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

Do not use this product for longer than 4 weeks unless recommended by a dentist or physician.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Use twice per day (morning and evening) in place of regular toothpaste or as recommended by a dentist or physician.

Adults and children 12 years of age and older: Twist off cap and remove foil seal. Apply at least a 1 inch strip gel onto a soft bristle tooth brush. Brush teeth thoroughly for at least 1 minute, spit out, and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth.

Children under 12 years of age: consult a dentist or physician.

Dosage Forms and Strengths (DOSAGE FORMS AND STRENGTHS)

Gel containing 1.1% sodium fluoride and 5% potassium nitrate.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:33:34.180397 · Updated: 2026-03-14T21:37:53.683254