Iolite
Benzocaine · Gel · Dental, Oral
Active ingredient
Active Ingredient Benzocaine, 20%
Purpose
Purpose Oral anesthetic
Uses
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
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.
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
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.
Inactive ingredients
Inactive Ingredients FD&C Red #40, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Label text from the FDA structured product label by Dharma Research, Inc. (revised Oct 10, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Benzocaine in 8 products
Iolite NDC products (8)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 53045-130 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-131 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-132 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-133 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-134 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-135 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-136 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
| 53045-138 | Benzocaine 6.4 g/100g Gel | Dharma Research, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Iolite used for?
Uses For the temporary relief of pain associated with canker sores and minor dental procedures.
Who makes Iolite?
Iolite is listed by 1 labeler in the FDA NDC directory, including Dharma Research, Inc..