Benzocaine-Butamben-Tetracaine Topical

Benzocaine/butamben/tetracaine is a topical anesthetic used on mucosal membranes to suppress the gag reflex, control pain and ease discomfort during dental and medical procedures.

• Benzocaine-Butamben-Tetracaine Topical is available under the following different brand names: Cetacaine

Common side effects of Benzocaine-Butamben-Tetracaine Topical include:

• redness
• itching
• swelling
• hives
• irritation
• rash at the site of application

Serious side effects of Benzocaine-Butamben-Tetracaine Topical include:

• hives
• itching
• red, swollen, blistered, or peeling skin with or without fever
• wheezing
• tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness
• swelling of the mouth, face, lips, tongue, or throat

Rare side effects of Benzocaine-Butamben-Tetracaine Topical include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical gel

1. 14%/2%/2%

Topical liquid

• 14%/2%/2%

Ointment

• 14%/2%/2%

Topical aerosol

• 14%/2%/2%

Topical anesthetic

Adult dosage

• Minor dermal procedure
  • Normal intact skin for local analgesia: Apply 2.5 g of cream over 20 to 25 cm of the skin surface or 1 anesthetic disc (1 g over 10 cm) for at least 1 hour
• Major dermal procedure
  • Apply 2 g of the cream per 10 cm of the skin surface and allow it to remain in contact with the skin for at least 2 hours
• Genital mucous membrane
  • Male genital skin: Apply a thick layer of cream (1 g/10 cm) to the skin surface for 15 minutes
  • Perform local anesthetic infiltration immediately after removal of the cream
  • Female genital mucous membranes: Apply a thick layer (5 to 10 g) of cream for 5 to 10 minutes

Pediatric dosage

Intact skin only

• Children aged between 0 and 3 months or weighing less than 5 kg: Apply 1 g per 10 cm for a maximum of 1 hour
• Children aged between 3 and 12 months and weighing more than 5 kg: Apply 2 g per 20 cm for a maximum of 4 hours
• Children aged between 1 and 6 years and weighing more than 10 kg: Apply 10 g per 100 cm for a maximum of 4 hours
• Children aged between 7 and 12 years and weighing more than 20 kg: Apply 20 g per 200 cm for a maximum of 4 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Benzocaine-Butamben-Tetracaine Topical has no noted severe interactions with any other drugs.
• Benzocaine-Butamben-Tetracaine Topical has no noted serious interactions with any other drugs.
• Benzocaine-Butamben-Tetracaine Topical has no noted moderate interactions with any other drugs.
• Benzocaine-Butamben-Tetracaine Topical has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to local anesthetics of the amide type or any component of the product

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Benzocaine-Butamben-Tetracaine Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Benzocaine-Butamben-Tetracaine Topical?”

Cautions

• Application to larger areas or for longer than the recommended period could result in sufficient absorption, causing serious adverse reactions

Pregnancy and Lactation

• May be acceptable during pregnancy
• Lactation
  • Unknown whether the medication is distributed in breast milk; caution advised