Label: IONITE H- sodium fluoride, potassium nitrate gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 2, 2015

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  • 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)

    20150802 280 NaFKNO3 Spmnt RevA

  • INGREDIENTS AND APPEARANCE
    IONITE H 
    sodium fluoride, potassium nitrate gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-280
    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
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-280-04122 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(53045-280)
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