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  5. Label Information: Iolite

FDA Label for Iolite

View Indications, Usage & Precautions

Table of Contents

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

Iolite 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



Benzocaine, 20%


Purpose



Oral anesthetic


Uses



For the temporary relief of pain associated with canker sores and minor dental procedures.


Warnings



Alergy alert.   Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.


Otc - Do Not Use



Do not use this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly.


Other



Do not exceed recommended dosage.


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children  If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.


Directions



  • Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age should be supervised in the use of this product
  • Children under 2 years of age: Consult a dentist or doctor.

Other Information



Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.


Inactive Ingredients



FD&C Red #3, FD&C Blue #1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol, Water


Iolite



Oral Anesthetic Gel Concord Grape

with Vitamin E and Xylitol

Gluten Free

1.12 oz (32 g)

Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

1-877-833-3725

www.dharmaresearch.com


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