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Ionite H

Generic Name: sodium fluoride, potassium nitrate
Dosage Form: gel, dentifrice

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Indications and Usage for Ionite H

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.

Ionite H 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

Ionite H 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).

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 53045-281-04

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)

Ionite H 
sodium fluoride, potassium nitrate gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53045-281
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg  in 100 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 5 mg  in 100 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
EDETIC ACID  
GLYCERIN  
SODIUM HYDROXIDE  
SODIUM POLYMETAPHOSPHATE  
TRICALCIUM PHOSPHATE  
water  
XYLITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:53045-281-04 122 g in 1 TUBE
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 Operations
Dharma Research, Inc. 078444642 manufacture(53045-281)
Revised: 08/2015
 
Dharma Research, Inc.
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