Manufacturing Establishments (1)
Dharma Research, Inc.
078444642
Products (1)
Ionite H
53045-281
DENTAL
August 2, 2015
Drug Labeling Information
DESCRIPTION SECTION
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.
INDICATIONS & USAGE SECTION
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.
CONTRAINDICATIONS SECTION
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.
HOW SUPPLIED SECTION
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
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
Alpha-tocopheryl, carbopol, edetic acid, flavor, glycerin, sodium hydroxide, sodium polymetaphosphate, tricalcium phosphate, water, xylitol