SPL v7
SPL
SPL Set ID 9991de96-99a1-42f0-9ddd-e530ca9ceab1
Route
DENTAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (11.4 g)
Inactive Ingredients
Polyethylene Glycol 400 Saccharin Sodium Alcohol Isobutane Propane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-29

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.
  • For Professional Use Only.
Section 51945-4

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 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use

  • for teething
  • in children under 2 years of age
Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

  • Children under 2 years of age: do not use
Active Ingredient

Benzocaine 20%

Inactive Ingredients

Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

other Information

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Questions Or Comments?

1-800-333-3131

keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes.


Structured Label Content

Uses
  • For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
  • For Professional Use Only.
Section 51945-4 (51945-4)

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 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Do not use

  • for teething
  • in children under 2 years of age
Directions

Apply only amount needed to the oral mucosa to prevent or relieve pain.

  • Children under 2 years of age: do not use
Active Ingredient

Benzocaine 20%

Inactive Ingredients

Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane).

other Information (Other information)

Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.

Questions Or Comments? (Questions or comments?)

1-800-333-3131

keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. Avoid spraying in eyes.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)