IONITE H- sodium fluoride, potassium nitrate gel, dentifrice 
Dharma Research, Inc.

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.

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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).

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)

20150802 281 NaFKNO3 BubGum RevA

IONITE H 
sodium fluoride, potassium nitrate gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-281
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
.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    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-281-04122 g in 1 TUBE; Type 0: Not a Combination Product08/02/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/02/2015
Labeler - Dharma Research, Inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, Inc.078444642manufacture(53045-281)

Revised: 8/2015
Document Id: ab938727-9383-48ce-a7a6-ed39d7d3ef15
Set id: 642fec99-c5c5-4ef2-986e-5b5f7cf460de
Version: 1
Effective Time: 20150802
 
Dharma Research, Inc.