Iolite-S 12 g/100mL
Benzocaine · SPRAY · Dharma Research, Inc.
Iolite-S is a prescription spray containing benzocaine at 12 g/100mL, taken dental. Manufactured by Dharma Research, Inc..
Key Facts
- Brand Name
- Iolite-S
- Generic Name
- Benzocaine
- NDC Code (Product)
53045-127- Manufacturer
- Dharma Research, Inc.
- Strength
- 12 g/100mL
- Dosage Form
- SPRAY
- Route
- DENTAL
- Marketing Status
- HUMAN OTC DRUG
- Application #
- M022
- Drug Class
- Allergens [CS]; Cell-mediated Immunity [PE]
- Marketing Start
- 01/04/2021
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 occasional minor irritation and pain associated with canker sores and minor dental procedures.
Dosage & Administration
Directions Shake well before use. Firmly insert extension tube into spray can valve and ensure it fits securely in the actuator opening. Position the extension tube 1-2 inches from the affected area. Press 1/2 second (press and immediately release the actuator). Adults and children 12 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: do not use.
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 use this product before. Stop use and seek immediate 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 Allergy 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 doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persist or worsens, or if swelling, rash, or fever develops, see your dentist or doctor promptly. For teething In children under 2 years of age Do not use near fire or flame. Flammable. Do not exceed recommended dosage. Avoid spraying in the eyes. Keep out of reach of children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control Center…
Frequently Asked Questions
What is Iolite-S used for?
Iolite-S contains Benzocaine. It is a spray taken dental. Consult your doctor for specific uses.
Is Iolite-S a controlled substance?
Iolite-S is not classified as a controlled substance by the DEA.
What is the generic name for Iolite-S?
The generic name for Iolite-S is Benzocaine. There are 12 other brand versions of Benzocaine.
What is the NDC code for Iolite-S 12 g/100mL?
The NDC (National Drug Code) for Iolite-S 12 g/100mL is 53045-127, listed by Dharma Research, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)