SPL v2
SPL
SPL Set ID 9f81ffa5-05fd-4eef-e053-2995a90aac3e
Route
DENTAL
Published
Effective Date 2020-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 3350 Polyethylene Glycol 400 Saccharin Sodium Fd&c Yellow No. 5 Fd&c Yellow No. 6 Fd&c Red No. 3 Fd&c Red No. 40 Fd&c Blue No. 1 Fd&c Green No. 3 D&c Red No. 28 D&c Green No. 5 Water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-10-01

Description

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 200mg (in each g)

Use

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

Section 50565-1

Keep out of reach of children.

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.

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.

Directions
  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use
Other Information

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

Active Ingredients 

Benzocaine 200mg (in each g)

Inactive Ingredients

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


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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.

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.

Directions
  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use
Other Information

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

Active Ingredients 

Benzocaine 200mg (in each g)

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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