SPL v1
SPL
SPL Set ID b3b68914-2adc-4f07-9521-0b18756be522
Route
DENTAL
Published
Effective Date 2025-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (12 g)
Inactive Ingredients
Alcohol Isobutane Polyethylene Glycol 400 Propane Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-04

Description

Benzocaine 20%

Purpose

Oral anesthetic


Medication Information

Purpose

Oral anesthetic

Description

Benzocaine 20%

Uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

Section 42229-5

Do not exceed recommended dosage.

Avoid spraying in the eyes.

Section 50565-1

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.

Section 50570-1

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.

Section 51945-4

Warnings

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.
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.

Active Ingredient

Benzocaine 20%

Other Information

Store at room temperature 59-86°F (15-30°C).

Inactive Ingredients

Ethyl alcohol, Flavor, Isobutane (propellant), Polyethylene glycol, Propane (propellant), Saccharine sodium.

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

Structured Label Content

Uses

For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.

Section 42229-5 (42229-5)

Do not exceed recommended dosage.

Avoid spraying in the eyes.

Section 50565-1 (50565-1)

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.

Section 50570-1 (50570-1)

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.

Section 51945-4 (51945-4)

Purpose

Oral anesthetic

Warnings

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.
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.

Active Ingredient

Benzocaine 20%

Other Information

Store at room temperature 59-86°F (15-30°C).

Inactive Ingredients

Ethyl alcohol, Flavor, Isobutane (propellant), Polyethylene glycol, Propane (propellant), Saccharine sodium.

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

Advanced Ingredient Data


Raw Label Data

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