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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. WARNINGS
    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, 0.4%


Purpose



Anticavity


Uses



Aids in the prevention of dental cavities (caries).


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Warnings



Supervision of children is required when using this product.  Developing teeth of children under six years of age may become permanently discolored if excessive amounts are repeatedly swallowed.


Directions



• This is not a toothpaste. Read directions carefully before using.
• Adults and children 6 years of age and older:
   o Use once per day after brushing teeth thoroughly with toothpaste
   o Twist off cap to remove foil seal
   o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.
   o Allow the gel to remain on your teeth for 1 minute
   o Spit out. Do not swallow
   o Do not eat, drink, or rinse for at least 30 minutes
• 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



Carbopol, citric acid, flavor, glycerin, sodium hydroxide, water, xylitol


Other



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 53045-270-04

Home Care

0.4% Stannous Fluoride Gel with Xylitol

Anticavity Fluoride Preventative Treatment Gel

Spearmint

Made in USA

Gluten Free Dye Free

Reorder#: 56-00130

4.3 oz. (122 g)


* Please review the disclaimer below.