Cetacaine Topical Anesthetic

The onset of Cetacaine-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.

Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia.

Spray in excess of two seconds is contraindicated. Average expulsion rate of residue from spray, at normal temperatures, is 200 mg per second.

To apply, insert the Jetco cannula (J-4) firmly onto the protruding plastic stem on the bottle and press the cannula forward to actuate the spray valve. The cannula may be removed and reinserted as many times as required for cleaning, or sterilization, and is autoclavable.

Cetacaine Liquid Apply 200 mg (approximately 0.2 mL) with a cotton applicator or directly to tissue. Do not hold the cotton applicator in position for extended periods of time, since local reactions to benzoate topical anesthetics are related to the length of time of application. Liquid in excess of 400 mg (approximately 0.4 mL) is contraindicated.

*See Cetacaine Liquid Kit instructions for additional directions for application by Luer-lock syringe and delivery tip.

Cetacaine Gel Dispense and apply 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump. Application of gel in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab.

An appropriate pediatric dosage has not been established for Cetacaine Spray, Liquid or 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. Cetacaine should be applied directly to the site where pain control is required. Anesthesia is produced within one minute with an approximate duration of thirty minutes. Each 200 mg dose of Cetacaine (Spray residue, Liquid or Gel) contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.

NDC 10223-0202-4
Item No. 0211

Cetacaine®
Topical Anesthetic
LIQUID

With Luer-lock
Dispenser Cap

30g

Control Pain
Effective Only on
Mucous Membrane

CETYLITE®

Hypersensitivity Reactions:   Unpredictable adverse reactions (ie, 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 charaterized 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 a two second spray. 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 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 is used.

Appropriate pediatric dosage has not been established for this product.

Cetacaine is not suitable and should never be used for injection. Do not use on the 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. Dosage should be reduced in the debilitated elderly, acutely ill, and very young patients.

Individual dosage of tetracaine hydrochloride in excess of 20 mg is contraindicated. 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.

Jetco Cannula for Cetacaine Spray

• The supplied 4" stainless steel Jetco cannula (J-4) for Cetacaine Spray is especially designed for accessibility and application of Cetacaine, at the required site of pain control.
• The Jetco cannula is also available in 6", (J-6) and 8" curved configuration, (J-8).
• Replacement Jetco cannulas are available.
• The Jetco cannula is inserted firmly into the protruding plastic stem on each bottle of Cetacaine Spray.
• The Jetco cannula may be removed and reinserted as many times as required for cleansing or sterilization, and is autoclavable.

PACKAGING AVAILABLE

Cetacaine Spray 56 g. including propellant.

Cetacaine Liquid 56 g.

Cetacaine Hospital Gel 29 g. Tube.

CAUTION

Federal law prohibits dispensing Cetacaine without prescription.

CETYLITE

INDUSTRIES, INC.

9051 River Road

Pennsauken, NJ 08110-3293

1-800-257-7740

www.cetylite.com

Made in U.S.A.                                    Rev. 11/99

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