Cetacaine Topical Anesthetic

Cetacaine Topical Anesthetic is an FDA-registered drug product whose active ingredient is BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE. It is labelled by Cetylite Industries, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 10223-0217, label effective 20220117. It is one of 2 FDA drug label records sharing the active ingredient BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE are most often described in connection with: topical anesthetic, indications cetacaine, production anesthesia, accessible mucous, membrane except, gel indicated, control pain, surgical endoscopic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures where feasible.

Dosage and Administration Only a limited quantity of Cetacaine Topical Anesthetic Gel is required for anesthesia. Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump. Dispensing a bead of gel in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab. In the unlikely event that a Cetacaine Gel pump jar won't dispense, attempt the following: Using a gloved hand, depress the pump fully using the thumb and middle finger. While depressed, cover the center orifice with the index finger. With the orifice still covered, slowly allow the pump to return to its original starting position. Repeat until Cetacaine Gel is dispensed (usually about 3-4 repeated attempts). An appropriate pediatric dosage has not been established for Cetacaine Topical Anesthetic Gel. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients. Do not use Cetacaine Gel to treat infants or children younger than 2 years. Tissue need not be dried prior to application of Cetacaine Topical Anesthetic Gel. Cetacaine Topical Anesthetic Gel should be applied directly to the site where pain control is required. Anesthesia is produced in approximately 30 seconds with an approximate duration of thirty to sixty minutes. Each 200 mg dose of Cetacaine Topical Anesthetic Gel contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

Contraindications Do not use Cetacaine Gel to treat infants or children younger than 2 years. Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine Topical Anesthetic Gel should not be applied to large areas of denuded or inflamed tissue. Cetacaine Topical Anesthetic Gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with status of the patient. Cetacaine Topical Anesthetic Gel should not be used under dentures or cotton rolls, as retention of the active gel ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine Topical Anesthetic Gel.

WARNINGS AND PRECAUTIONS Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Cetacaine and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

FDA lists 2 drug label records with BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cetacaine Topical Anesthetic used for?
Indications Cetacaine Topical Anesthetic Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Topical Anesthetic Gel is indicated for use to control pain and for use for surgical or endoscopic procedures, or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used …

Who makes Cetacaine Topical Anesthetic?
Cetylite Industries, Inc. is the labeler of record for Cetacaine Topical Anesthetic. 2 FDA label records share the active ingredient BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cetacaine Topical Anesthetic come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cetacaine Topical Anesthetic prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE?
Yes. 2 FDA drug label records list BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cetacaine Topical Anesthetic been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.