1009afc7-6e9d-417f-a702-f8a941e08484
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Indications and Usage
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Warnings and Precautions
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
Contraindications
Avoid use in patients with known hypersensitivity to fluoride
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
64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
Medication Information
Warnings and Precautions
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
Indications and Usage
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Contraindications
Avoid use in patients with known hypersensitivity to fluoride
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
64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
Description
Ionite R Fluoride Oral Rinse is a flavored, pH neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay.
ACTIVE INGREDIENT: Sodium Fluoride, 2.0%
INACTIVE INGREDIENTS: Flavor, Water, Sodium Benzoate, Sodium Citrate, Saccharin Sodium, Xylitol
How Supplied/storage
64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
Dosage Form and Strength
Liquid containing 2% sodium fluoride
Ionite R Sodium Fluoride Rinse
2.0% Neutral Sodium Fluoride
Dye Free
Fruit Punch
With Xylitol
Gluten Free
Rx Only
64 fl. oz. (1.9 L)
Manufactured by:
Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166
1-877-833-3725
www.dharmaresearch.com
NDC 53045-266-64
Label Revision B, 10/29/13
Structured Label Content
Description (DESCRIPTION)
Ionite R Fluoride Oral Rinse is a flavored, pH neutral 2.0% sodium fluoride treatment rinse that aids in the prevention of dental decay.
ACTIVE INGREDIENT: Sodium Fluoride, 2.0%
INACTIVE INGREDIENTS: Flavor, Water, Sodium Benzoate, Sodium Citrate, Saccharin Sodium, Xylitol
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
How Supplied/storage (HOW SUPPLIED/STORAGE)
64 fluid ounces (1.9 L) in a plastic bottle with dispensing pump included. Store at room temperature 59-86°F (15-30°C). Protect from freezing.
Indications and Usage (INDICATIONS AND USAGE)
This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.
Dosage Form and Strength (DOSAGE FORM AND STRENGTH)
Liquid containing 2% sodium fluoride
Warnings and Precautions (WARNINGS AND PRECAUTIONS)
Do not swallow. Keep out of reach of children. Read prescribing information fully before using this product. Use in children less than 6 years of age requires special supervision to prevent swallowing. If product is accidentally swallowed in quantities greater than would normally occur with a rinse, seek medical help right away.
Ionite R Sodium Fluoride Rinse
2.0% Neutral Sodium Fluoride
Dye Free
Fruit Punch
With Xylitol
Gluten Free
Rx Only
64 fl. oz. (1.9 L)
Manufactured by:
Dharma Research, Inc., 5220 NW 72nd Avenue, Unit 15, Miami, FL, 33166
1-877-833-3725
www.dharmaresearch.com
NDC 53045-266-64
Label Revision B, 10/29/13
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:35:35.539512 · Updated: 2026-03-14T21:43:53.176157