FDA Label for Cetacaine Topical Anesthetic

Other

Rx Only

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

Made in USA
Rev. 03/17

Description

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.

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.

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 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.

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.

How Supplied

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

Principal Display Panel - 32 G Jar Box - Strawberry

NDC 10223-0217-3
Item# 0217

Cetacaine^®
Topical Anesthetic GEL

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

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

Strawberry Flavor

Net Contents: 32 g

Rev. 02/17

PRINCIPAL DISPLAY PANEL - 32 g Jar Box - Strawberry - cetacaine 01

Principal Display Panel - 32 G Jar Box - Mint

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

PRINCIPAL DISPLAY PANEL - 32 g Jar Box - Mint - cetacaine 02