BencoCaine Topical Anesthetic: Package Insert and Label Information

BENCOCAINE TOPICAL ANESTHETIC- benzocaine gel
Benco Dental

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic

Use

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

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

Keep out of reach of children.

Other Information

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

Inactive Ingredients

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.

Questions or comments?

800.GO.BENCO or benco.com

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BENCOCAINE TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66975-357
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color red Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66975-357-30 30 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/27/2014
Labeler — Benco Dental (015108087)

Revised: 11/2018 Benco Dental

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