Cetacaine Anesthetic

Cetacaine 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 10223-0201, 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: control pain, indications cetacaine, topical anesthetic, production anesthesia, accessible mucous, membrane except, spray indicated, surgical endoscopic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Dosage and Administration Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia. Spray in excess of two seconds is contraindicated. Each one-second spray contains an average of 200 mg of product, not including propellant. To apply, insert the cannula firmly onto the protruding plastic stem on the bottle and press the cannula forward to actuate the spray valve. The cannula may be removed and reinserted as many times as required for cleaning, or sterilization, and is autoclavable. Cetacaine Liquid Apply 200 mg liquid (approximately 0.2 mL) directly to tissue. Liquid in excess of 400 mg (approximately 0.4 mL) is contraindicated. To apply, remove and discard the shipping cap from the bottle. Replace it with the supplied Luer-lock cap. Caution: Do not over-tighten. Remove small cap from luer-lock port, retaining it for replacement after use. Port allows for a single dip of a cotton or brush applicator for application directly to accessible mucous membrane. For application into periodontal pockets, Cetylite Luer-lock syringes and Microcapillary Delivery Tips are recommended. Cetylite Syringes are clearly marked in (4) 0.1 mL increments. To fill, attach syringe to port by gently twisting clockwise until secure. Invert and draw desired amount of liquid into the syringe. Remove filled syringe and attach Microcapillary Delivery Tip to the syringe. Tip may be bent to improve access. Apply dropwise to accessible mucous membrane (such as buccal and lingual sulcus) by slowly depressing the syringe plunger. Discard all applicators after use. An appropriate pediatric dosage has not been established for Cetacaine Spray or Cetacaine Liquid. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients (i.e., children 2 years and older). Do not use Cetacaine Spray or Cetacaine Liquid to treat infants or children younger than 2 years. Tissue need not be dried prior to application of Cetacaine. Cetacaine should be applied directly to the site where pain control is required. Anesthesia is produced within one minute with an approximate duration of thirty minutes. Each 200 mg dose of Cetacaine (Spray or Liquid) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

Contraindications Do not use Cetacaine Spray or Cetacaine Liquid 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 should not be applied to large areas of denuded or inflamed tissue. Cetacaine 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 the status of the patient. Cetacaine should not be used under dentures or cotton rolls, as retention of the active 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.

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

Who makes Cetacaine Anesthetic?
Cetylite Industries, Inc. is the labeler of record for Cetacaine 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 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 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 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.