SPL v2
SPL
SPL Set ID e816b8cd-14cc-4cc8-9498-03fa1cc5b45c
Route
DENTAL
Published
Effective Date 2018-03-29
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 Water Fd&c Blue No. 1 D&c Green No. 5 Fd&c Red No. 3 D&c Red No. 28 Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-01

Description

Benzocaine 200 mg

Purpose

Oral Anesthetic


Medication Information

Purpose

Oral Anesthetic

Description

Benzocaine 200 mg

Use

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

Section 51945-4

Warnings
  • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • ​Do Not Use​ for more than 7 days unless directed by a dentist or doctor. 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 dentist or doctor promptly.
  • ​When using this product​ avoid contact with eyes. If contact occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
  • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • ​If pregnant or breast feeding, ​ask a health professional before use. 
​directions

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

​other Information

Store at 59º -86°F (15 - 30°C).

Protect from freezing.

Questions Or Comments?

1-262-636-9755

​inactive Ingredients

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

Active Ingredients (in Each Gram)

Benzocaine 200 mg

​keep Out of Reach of Children.

Keep Out of Reach of Children.


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 51945-4 (51945-4)

Purpose

Oral Anesthetic

Warnings
  • ​Allergy Alert:​ Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
  • ​Do Not Use​ for more than 7 days unless directed by a dentist or doctor. 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 dentist or doctor promptly.
  • ​When using this product​ avoid contact with eyes. If contact occurs, flush with water.
  • ​Stop use and consult a health care practitioner​ if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
  • ​Do not exceed recommended dosage.​ If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
  • ​If pregnant or breast feeding, ​ask a health professional before use. 
​directions (​Directions)

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

​other Information (​Other Information)

Store at 59º -86°F (15 - 30°C).

Protect from freezing.

Questions Or Comments? (Questions or comments?)

1-262-636-9755

​inactive Ingredients (​Inactive ingredients)

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

Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Benzocaine 200 mg

​keep Out of Reach of Children. (​Keep Out of Reach of Children.)

Keep Out of Reach of Children.


Advanced Ingredient Data


Raw Label Data

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