Active Ingredient
Benzocaine, 20%
Iolite Gel
FDA Label NDC 53045-133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Iolite (NDC 53045-133). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, other, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 a 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 #40, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Iolite
Oral Anesthetic Gel Mango Frappe
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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