SPL v1
SPL
SPL Set ID 3f199947-bf25-914b-e063-6394a90a8a6f
Route
DENTAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Saccharin Sodium Polyethylene Glycol 400 Polyethylene Glycol 3350

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Benzocaine 200mg (in each g)


Medication Information

Warnings and Precautions

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of o 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.

Do not use

  • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a physician before use.

Indications and Usage

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Dosage and Administration
  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use
Description

Benzocaine 200mg (in each g)

Section 44425-7

Store at 59°-86°F (15°-30°C). Protect from freezing.

Section 50565-1

Keep out of reach of children.

Section 51727-6

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Section 51945-4

Section 53413-1

800.873.7683

Section 55105-1

Oral Anesthetic

Section 55106-9

Benzocaine 200mg (in each g)


Structured Label Content

Indications and Usage (34067-9)

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

Dosage and Administration (34068-7)
  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use
Warnings and Precautions (34071-1)

Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of o 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.

Do not use

  • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
  • for teething
  • in children under 2 years of age

When using this product Avoid contact with eyes. If contact occurs, flush with water.

Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding, ask a physician before use.

Section 44425-7 (44425-7)

Store at 59°-86°F (15°-30°C). Protect from freezing.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

flavoring, PEG 3350, PEG 400, sodium saccharin. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

800.873.7683

Section 55105-1 (55105-1)

Oral Anesthetic

Section 55106-9 (55106-9)

Benzocaine 200mg (in each g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)