Indications and uses
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.
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.
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 u...
4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).
Ionite H Neutral Fluoride Gel, Sodium Fluoride, 1.1%, Potassium Nitrate, 5%, oral gel
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.
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.
Gel containing 1.1% sodium fluoride and 5% potassium nitrate.
Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.
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.
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
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.
Sodium Fluoride, 1.1%; Potassium Nitrate, 5%
Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol
4.3 ounces (122 g) in a plastic tube. Store at room temperature 59 – 86°F (15 – 30°C).
Manufactured by Dharma Research, Inc.
5220 N.W. 72 Avenue, Unit 15
Miami, FL 33166
1-877-833-3725
NDC 53045-281-04
Home Care
1.1% Neutral Fluoride Gel
with Xylitol and Vitamin E
Bubble Gum
Rx Only
Made in USA
Gluten Free Dye Free
Re-order#: 56-00141
4.3 oz. (122 g)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste | PSN | 1 |
| 637365 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste | SCD | 1 |
| 637365 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | 1 |
| 637365 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste | SY | 1 |
| 637365 | potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste | SY | 1 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53045-281-04 | Ionite H | 122 g in 1 TUBE | GEL, DENTIFRICE | 122 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POTASSIUM NITRATE | ACTIVE INGREDIENT | RU45X2JN0Z | 1 | |
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 1 | |
| NITRATE ION | ACTIVE MOIETY | T93E9Y2844 | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| EDETIC ACID | INACTIVE INGREDIENT | 9G34HU7RV0 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM POLYMETAPHOSPHATE | INACTIVE INGREDIENT | P1BM4ZH95L | 1 | |
| TRICALCIUM PHOSPHATE | INACTIVE INGREDIENT | K4C08XP666 | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53045-281 | 53045-281-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| POTASSIUM NITRATE | RU45X2JN0Z | ACTIB |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | IACT |
| EDETIC ACID | 9G34HU7RV0 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SODIUM POLYMETAPHOSPHATE | P1BM4ZH95L | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| water | 059QF0KO0R | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | LOTION / TOPICAL | 300 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SUPPOSITORY / RECTAL | 7 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / SUBMUCOSAL | 0.03 %w/v | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / INTRAMUSCULAR | 2 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SOLUTION / TOPICAL | 0.5 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 72 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM / TOPICAL | 103 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | GEL / TOPICAL | 0.1 %w/w | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM / TOPICAL | 103 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | FILM, SOLUBLE / ORAL | 29 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SUSPENSION, EXTENDED RELEASE / ORAL | 9000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.64 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | GUM, CHEWING / BUCCAL | 11915 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | OINTMENT, AUGMENTED / TOPICAL | 23 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| SODIUM POLYMETAPHOSPHATE | SODIUM POLYMETAPHOSPHATE | P1BM4ZH95L | SOLUTION / BUCCAL | NA | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL, METERED / TRANSDERMAL | 50 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | POWDER, FOR SUSPENSION / ORAL | 4223 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / INTRAVENOUS | 2 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET, ORALLY DISINTEGRATING / ORAL | 360 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | LOTION / TOPICAL | 300 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / DENTAL | ADJ PH | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | TABLET / ORAL | 15.04 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | CREAM / TOPICAL | 0.5 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL, METERED / TRANSDERMAL | 50 mg | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | SOLUTION / ORAL | 21600 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / INTRAMUSCULAR | 2 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | INJECTION, SOLUTION / SUBMUCOSAL | 0.03 %w/v | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SUSPENSION / TOPICAL | 0.06 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | EMULSION / TOPICAL | 6 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ionite H | SODIUM FLUORIDE, POTASSIUM NITRATE | Dharma Research, Inc. | 642fec99-c5c5-4ef2-986e-5b5f7cf460de | 2015-08-02 | Warnings, Adverse reactions | 53045-281-04 53045-281 53045028104 ab938727-9383-48ce-a7a6-ed39d7d3ef15 642fec99-c5c5-4ef2-986e-5b5f7cf460de |
Adverse event summaries are temporarily unavailable. Other product information remains available.