SPL v6
SPL
SPL Set ID 2cd571fc-30ee-40da-a2c7-25adb7d4b5c3
Route
DENTAL
Published
Effective Date 2022-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-01

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.
Dosage

​A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

Section 51945-4

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a setious condition that must be treated promptiy because it reduces the amount of oxygen canied in the blood. This can occur even if you have used this product before. Slop use and seek immediate medical attention tt you or a child in your care develops:

• pale, gray or blue colored skn (cyanosis)

• headache

• rapid heart rate

• shortress of breath

• dizziness or lightheadedness

• fatigue or lack of energy

Allergy Alert: Do not use if you have a history of allergy 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

Active Ingredient

Benzocaine 20%

Other Information

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

Inactive Ingredients

Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).

​questions Or Comments?

1-800-472-4346

​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 nght 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.
Dosage

​A single metered spray dispenses 50 mg of Benzo-Jel Topical Anesthetic. Use only as directed by a dentist.

Section 51945-4 (51945-4)

Purpose

Oral Anesthetic

Warnings

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a setious condition that must be treated promptiy because it reduces the amount of oxygen canied in the blood. This can occur even if you have used this product before. Slop use and seek immediate medical attention tt you or a child in your care develops:

• pale, gray or blue colored skn (cyanosis)

• headache

• rapid heart rate

• shortress of breath

• dizziness or lightheadedness

• fatigue or lack of energy

Allergy Alert: Do not use if you have a history of allergy 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

Active Ingredient

Benzocaine 20%

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.

Inactive Ingredients (Inactive ingredients)

Ethyl Alcohol, Flavor, Polyethelyn Glycol, Sodium Saccharin, Hydrocarbon Propellant (HFC-134a).

​questions Or Comments? (​Questions or comments?)

1-800-472-4346

​keep Out of Reach of Children. (​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 nght away. Avoid spraying in eyes.


Advanced Ingredient Data


Raw Label Data

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