IONITE H- sodium fluoride, potassium nitrate gel, dentifrice

Ionite H by

Drug Labeling and Warnings

Ionite H by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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.

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.

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

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.

ACTIVE INGREDIENTS

Sodium Fluoride, 1.1%; Potassium Nitrate, 5%

INACTIVE INGREDIENTS

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

HOW SUPPLIED/STORAGE

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

SPL UNCLASSIFIED SECTION

Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

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)

INGREDIENTS AND APPEARANCE

IONITE H 
sodium fluoride, potassium nitrate gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53045-280
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-280-04	122 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/02/2015

Labeler - Dharma Research, Inc. (078444642)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(53045-280)