This topical anesthetic is indicated for producing local anesthesia of accessible mucous membranes, except the eyes. It is used to control pain during surgical, diagnostic, or endoscopic procedures involving the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for certain vaginal or rectal procedures where appropriate.

Each 200 mg dose of this topical gel contains:

• Benzocaine — 28 mg
• Butamben — 4 mg
• Tetracaine Hydrochloride — 4 mg

This topical gel provides rapid onset of anesthesia, usually within about 30 seconds, with a duration of approximately 30 to 60 minutes when used as directed. The quick onset is primarily due to benzocaine, which acts rapidly but has a short duration. Tetracaine hydrochloride has a slower onset but a longer duration of action, while butamben provides an intermediate effect between the two. These agents act by reversibly blocking nerve conduction, thereby preventing the transmission of pain signals. The onset and duration depend on the rate of absorption through the mucous membrane. After metabolism, the components are excreted through the urine.

Dispense and apply 200 mg of gel (a bead approximately ¼ to ½ inches long) by gently squeezing the tube.
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 this topical gel. Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients Tissue need not be dried prior to application of this topical gel. It 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.

Pediatric Use: Safety and effectiveness of this gel in pediatric patients have not been established.

This topical gel is not intended for injection and must not be used in the eyes. To prevent excessive systemic absorption, it should not be applied to large areas of damaged, denuded, or inflamed tissue. It is contraindicated in patients with known hypersensitivity to any of its components or in those with cholinesterase deficiency. The gel should not be used under dentures or cotton rolls, as prolonged contact may cause tissue damage (escharotic effect). Standard precautions for topical anesthetics should always be followed.

Hypersensitivity reactions: Serious allergic reactions, including anaphylaxis, are extremely rare but possible. Prolonged or repeated use of aminobenzoate-type anesthetics may cause localized allergic reactions. The most common reaction is contact dermatitis, presenting with redness, itching, and sometimes progressing to blistering and oozing. If any signs of allergy such as rash, urticaria, or swelling occur, the medication should be discontinued immediately. Prolonged application may also lead to epithelial dehydration or tissue damage.

The safety of this gel during pregnancy has not been established. It should not be used during early pregnancy unless the potential benefits outweigh the risks. General precautions for topical anesthetics should be followed during use.

Rare cases of methemoglobinemia have been reported with benzocaine-containing products. Care should be taken not to exceed the recommended dose. If symptoms such as cyanosis occur, appropriate treatment (e.g., methylene blue) should be administered promptly.

Topical local anesthetics.

Store in a cool, dry place protected from light. Keep out of reach of children