db763237-2910-45b9-be72-da092edc951b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Benzocaine, 20%
Purpose
Oral anesthetic
Medication Information
Purpose
Oral anesthetic
Description
Benzocaine, 20%
Uses
For the temporary relief of pain associated with canker sores and minor dental procedures.
Iolite
Oral Anesthetic Gel Raspberry Jam
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
Section 50565-1
Keep Out of Reach of Children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control center right away.
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
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 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.
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.
Active Ingredient
Benzocaine, 20%
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 Blue #1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Structured Label Content
Uses
For the temporary relief of pain associated with canker sores and minor dental procedures.
Iolite
Oral Anesthetic Gel Raspberry Jam
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
Section 50565-1 (50565-1)
Keep Out of Reach of Children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control center right away.
Purpose
Oral anesthetic
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
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 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.
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.
Active Ingredient
Benzocaine, 20%
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 Blue #1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:23.606364 · Updated: 2026-03-14T23:01:22.645369