Data from FDA - Curated by EPG Health - Last updated 22 August 2017


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.

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Advisory information

Contraindications Cetacaine Topical Anesthetic Gel 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.
Special warnings and precautions
Precaution On rare occasions, methemoglobinemia has been reported in connection with the use of benzocaine-containing products. Care should be used not to exceed the maximum recommended dosage (see Dosage and Administration). If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).
Adverse reactions
Adverse Reactions Hypersensitivity Reactions Unpredictable adverse reactions (i.e. hypersensitivity, including anaphylaxis) are extremely rare. Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, Cetacaine Topical Anesthetic Gel should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.

Usage information

Dosing and administration
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.

More information

Category Value
Agency product number U3RSY48JW5
Orphan designation No
Product NDC 10223-0221,10223-0217
Date Last Revised 05-04-2017
RXCUI 308645
Marketing authorisation holder Cetylite Industries, Inc.