Cetacaine Topical Anesthetic Spray and Liquid

Rx Only.

Store at controlled room temperature 20-25°C (68-77°F)

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.

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 is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine Spray is indicated for use to control pain or gagging.

Cetacaine in all forms is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.

Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents:

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Do not use Cetacaine Spray or Cetacaine Liquid to treat infants or children younger than 2 years.

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.

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.

• The supplied 4" stainless steel cannula for Cetacaine Spray is specially designed for accessibility and application of Cetacaine, at the required site of pain control. Replacement cannulas are available as a 10-pack (Item # 0205).

• Cetacaine Liquid Syringes and Microcapillary Delivery Tips are supplied with the Cetacaine Liquid Chairside Kit (Item # 0218) and Clinical Kit (Item # 0212). They also can be purchased separately. Syringes are available in packs of 50 (Item # 0219S) or packs of 100 (Item # 0214). Delivery Tips are available in packs of 50 (Item # 0219T) or packs of 100 (Item # 0213).

• Cetacaine Spray, 20 g bottle, including propellant¹ (Item # 0220, NDC 10223-0201-3) which includes one cannula.
• Cetacaine Spray Single Patient Use, 5 g bottle, including propellant¹ (Item # 0222, NDC 10223-0201-4) which includes one cannula.
• Cetacaine Liquid Chairside Kit (Item # 0218 NDC 10223-0202-6) which includes one 14 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 20 syringes and 20 delivery tips.
• Cetacaine Liquid Clinical Kit (Item # 0212, NDC 10223-0202-5) which includes one 30 g bottle of Cetacaine Liquid with Luer-lock dispenser cap, 100 syringes and 100 delivery tips.
• Cetacaine Liquid, 14 g bottle (Item # 0203, NDC 10223-0202-2) with Luer-lock dispenser cap.
• Cetacaine Liquid, 30 g bottle (Item # 0211, NDC 10223-0202-4) with Luer-lock dispenser cap.

Made in USA

Cetylite Industries, Inc.
Pennsauken, NJ 08110

Rev. 10 /18

www.cetylite.com

NDC 10223-0202-7
Item No. 0223

Cetacaine^®
Topical Anesthetic
LIQUID

With Luer-lock
Dispenser Cap

11g

Control Pain
Effective Only on
Mucous Membrane

CETYLITE^®

NDC 10223-0202-8
Item No. 0224

Cetacaine^®
Topical Anesthetic
LIQUID

With Luer-lock
Dispenser Cap

24g

Control Pain
Effective Only on
Mucous Membrane

CETYLITE^®

OPEN HERE

Cetacaine^®

Topical Anesthetic

LIQUID

(Benzocaine 14.0%, Butamben 2.0%, and Tetracaine Hydrochloride 2.0%)

Chairside Kit

CETYLITE^®

NDC 10223-0226-1
ITEM NO: 0226

Cetacaine^®
TOPICAL ANESTHETIC LIQUID CLINICAL KIT
(Benzocaine 14.0%, Butamben 2.0%, and Tetracaine HCl 2.0%)

Featuring a Unique Dispenser Cap for Accurate Filling of Luer-lock Syringes

KIT CONTAINS:

1 24g bottle of Cetacaine Liquid

1 Luer-lock dispenser cap

100 Microcapillary Delivery Tips

100 Delivery Syringes

CETYLITE^®

Rx Only

CAUTION: Not for injection. Do not use on the eyes. Keep out of reach of children.