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  5. Label Information: Ionite H

FDA Label for Ionite H

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. OTC - DO NOT USE
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. OTHER
    10. IONITE H

Ionite H Product Label

The following document was submitted to the FDA by the labeler of this product Dharma Research, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Stannous fluoride, 0.63%


Purpose



Anticavity/antigingivitis


Uses



  • Aids in the prevention of dental decay
    • Helps prevent gingivitis
      • Helps interfere with harmful effects of plaque associated with gingivitis

Otc - Keep Out Of Reach Of Children



Keep out of reach of children under 6 years of age.  If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away.


Otc - Do Not Use



Do not swallow.


Directions



• Do not use before mixing with water
• Adults and children 6 years of age and older:
   - Use once per day after brushing your teeth with toothpaste
   - Remove cap and replace with pump
   - Rotate spout counter clockwise to extend
   - Depress pump until rinse comes to the tip of the pump
   - Pump 1/8 fl. oz. into a cup.
   - Add water to the line (1 fl. oz.) on cup.
   - Mix using bristle end of toothbrush
   - Vigorously swish rinse between your teeth for 1 min. and then spit out.
   - Do not swallow the rinse
   - Do not eat or drink for 30 min. after rinsing
   - Instruct children under 12 in good rinsing habits to minimize swallowing.
   - Supervise children as necessary until capable of using without supervision
• Children under 6: Consult a dentist or doctor


Other Information



  • Store at room temperature 59 – 86°F (15 – 30°C).
    • This product may produce surface staining of the teeth.  Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive Ingredients



Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol


Other



Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

Reorder#: 56-00135


Ionite H



NDC 53045-275-10

PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

0.63 Stannous Fluoride Concentrate with Xylitol

Alcohol Free

Spearmint

IMPORTANT: Read directions for proper use.

Made in USA

Dye Free Gluten Free Paraben Free

Home Care

10 fl. oz. (296 mL)


* Please review the disclaimer below.