SPL v3
SPL
SPL Set ID db763237-2910-45b9-be72-da092edc951b
Routes
ORAL DENTAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (6.4 g)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Blue No. 1 Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium .alpha.-tocopherol Acetate Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-23

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)