Iolite 6.4 g/100g
Benzocaine · GEL · Dharma Research, Inc.
Iolite is a gel containing benzocaine at 6.4 g/100g, taken dental. Manufactured by Dharma Research, Inc..
Key Facts
- Brand Name
- Iolite
- Generic Name
- Benzocaine
- NDC Code (Product)
53045-135- Manufacturer
- Dharma Research, Inc.
- Strength
- 6.4 g/100g
- Dosage Form
- GEL
- Route
- DENTAL, ORAL
- Marketing Status
- Application #
- M022
- Drug Class
- Standardized Chemical Allergen [EPC]
- Marketing Start
- 07/23/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Dosage & Administration
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.
Warnings
Warnings Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatigue or lack of energy 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. 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. Do not exceed recommended dosage.
Frequently Asked Questions
What is Iolite used for?
Iolite contains Benzocaine. It is a gel taken dental. Consult your doctor for specific uses.
Is Iolite a controlled substance?
Iolite is not classified as a controlled substance by the DEA.
What is the generic name for Iolite?
The generic name for Iolite is Benzocaine. There are 12 other brand versions of Benzocaine.
What is the NDC code for Iolite 6.4 g/100g?
The NDC (National Drug Code) for Iolite 6.4 g/100g is 53045-135, listed by Dharma Research, Inc..
Other Benzocaine Brands
See all →- Oral Pain Relief Gel200 mg/g81417-001
- INTIMALE Benzocaine Delay Gel50 mg/mL81923-369
- Maximum OTC Strength Feminine Anti-Itch Creme5.67 g/28g83324-019
- Cetacaine Anesthetic.028 g/.2g10223-0202
- Topicale180 mg/g10733-166
- VAGISIL Anti-Itch Medicated Creme Maximum Strength200 mg/g11509-4402
- Toothache and Gum Relief Cushions10 g/100g11822-1616
- 4x Medicated Gum Cream.13 g/100g21130-621
- Topcare Maximum Strength20 g/100g36800-443
- Vicks VapoCool Sore Throat5 g/100mL37000-928
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)