Cetacaine Topical Anesthetic Gel

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.

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.

Safe use of Cetacaine Topical Anesthetic Gel has not been established with respect to possible adverse effects upon fetal development. Therefore, Cetacaine Topical Anesthetic Gel should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine Topical Anesthetic Gel is used.

Cetacaine Topical Anesthetic Gel (Strawberry), 32 g jar

NDC 10223-0217-3
Item# 0217

Cetacaine Topical Anesthetic Gel (Mint), 32 g jar

NDC 10223-0221-1
Item# 0221

Cetylite Industries, Inc.
Pennsauken, NJ 08110
www.cetacaine.com

Made in USA
Rev. 03/17

NDC 10223-0221-1
Item# 0221

Cetacaine®
Topical Anesthetic GEL

(14% Benzocaine, 2% Butamben, and 2% Tetracaine Hydrochloride)

Indicated for anesthesia of all
accessible mucous membrane
except the eyes.

Cool Mint Flavor

Net Contents: 32 g

Rev. 02/17