About Cetacaine

Cetacaine® Topical Anesthetics are the original fast-acting, long lasting prescription topical anesthetics with the triple-active formula (Benzocaine 14.0%, Butamben 2.0%, Tetracaine Hydrochloride 2.0%) It can be applied directly to the site where pain control is required. Cetacaine is primarily used to control pain, ease discomfort and suppress the gag reflex. Cetacaine is indicated for use:

  • For the production of anesthesia of all accessible mucous membrane except the eyes
  • To control gagging (spray only)
  • To control pain at the site where it is applied
  • For surgical or endoscopic or other procedures in the ear, nose, mouth and esophagus
  • For vaginal or rectal procedures

 
Cetacaine is available in spray, liquid, and gel forms.
Rx only.
Important Safety Information
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. If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated). 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.
Cetacaine is not right for everyone, including those who are hypersensitive to any of its ingredients or are known to have cholinesterase deficiencies. Please see the brief summary of the Prescribing Information on page six.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Contraindications:
Active Ingredients: Benzocaine 14.0 %, Butamben 2.0 %, Tetracaine Hydrochloride 2.0 %

Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. hypersensitivity, including anaphalaxis) 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 preparations 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.

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).

Use in Pregnancy: Safe use of Cetacaine has not been established with respect to possible adverse effects upon fetal development. Therefore, Cetacaine should not be used during early pregnancy, unless in the judgment of a physician, the potential benefits outweigh the unknown hazards.

Contraindications: Cetacaine is not suitable and should never be used for injection. Do not use in 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.