CETACAINE TOPICAL ANESTHETIC- benzocaine, butamben and tetracaine hydrochloride gel
Cetylite Industries, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Rx Only
Active Ingredients:
in a base consisting of polyethylene glycol, purified water, saccharin, cetyldimethylethylammonium bromide, flavoring and color
Benzocaine 14.0%
Butamben 2.0%
Tetracaine Hydrochloride 2.0%
Action
The onset of Cetacaine Topical Anesthetic Gel produced anesthesia is rapid (approximately 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. This effect is due to the rapid onset, but short duration of action of Benzocaine coupled with the slow onset, but extended duration of Tetracaine HCI and bridged by the intermediate action of Butamben.
It is believed that all of these agents act by reversibly blocking nerve conduction. Speed and duration of action is determined by the ability of the agent to be absorbed by the mucous membrane and nerve sheath and then to diffuse out, and ultimately be metabolized (primarily by plasma cholinesterases) to inert metabolites which are excreted in the urine.
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.
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 HCI.