Benzocaine + Butamben + Tetracaine topical

Benzocaine + Butamben + Tetracaine is a topical anesthetic cream that numbs the skin surface for various dermal procedures. It contains three active ingredients that stabilize neuronal membranes and inhibit ionic fluxes required for impulse initiation and conduction, producing local anesthetic effects.

This cream is used for minor dermal procedures (such as injections, blood draws) and major dermal procedures (such as laser treatments, skin biopsies) on normal intact skin. It can also be used on genital mucous membranes for minor surgeries.

• Minor dermal procedures
• Major dermal procedures
• Minor surgery on genital mucous membranes
• Pretreatment for infiltration anesthesia

Benzocaine, Butamben, and Tetracaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. This combination provides rapid onset and prolonged anesthetic effect.

Benzocaine and Butamben are ester-type local anesthetics, and Tetracaine is also an ester-type local anesthetic. They act on nerve endings at the application site to create temporary numbness.

Benzocaine, Butamben, and Tetracaine block sodium channels in neuronal membranes, preventing the initiation and conduction of impulses. This creates temporary numbness at the application site and reduces pain sensation.

Adults:

• Minor dermal procedure (local analgesia): Apply 2.5 g of cream over 20-25 cm² of skin surface for at least 1 hour.
• Major dermal procedure: Apply 2 g of cream per 10 cm² of skin surface for at least 2 hours.
• Male genital skin: Apply thick layer of cream (1 g/10 cm²) for 15 minutes; perform infiltration anesthesia immediately after removal.
• Female genital mucous membranes: Apply thick layer (5-10 g) of cream for 5-10 minutes.

Children (intact skin only):

• 0-3 months or <5 kg: Max 1 hour, 1 g per 10 cm² skin.
• 3-12 months & ≥5 kg: Max 4 hours, 2 g per 20 cm² skin.
• 1-6 years & >10 kg: Max 4 hours, 10 g per 100 cm² skin.
• 7-12 years & >20 kg: Max 4 hours, 20 g per 200 cm² skin.

For topical use only. Not for ophthalmic or otic use. Dermal analgesia can increase for up to 3 hours under occlusive dressing and persist for 1-2 hours after cream removal. Wash hands before and after application.

If you miss a dose, apply as needed. Do not double the dose.

• Paleness (37%)
• Erythema (30%)
• Burning sensation (17%)
• Edema (10%)
• Alterations in temperature sensations (7%)
• Itching (2%)
• CNS excitement or depression
• Lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness
• Sensations of hot, cold, or numbness
• Twitching, tremors, convulsions
• Bradycardia, hypotension, cardiovascular collapse
• Vomiting
• Purpuric or petechial reactions at application site, hyperpigmentation
• Redness, blistering (in neonates during circumcision)
• Tinnitus, blurred or double vision
• Allergic and anaphylactoid reactions (urticaria, angioedema, bronchospasm, shock)

• Application to larger areas or for longer than recommended could result in sufficient absorption causing serious adverse reactions
• Avoid if allergic to amide-type local anesthetics
• Do not apply to open wounds or broken skin
• Avoid contact with eyes and mucous membranes
• Blistering may occur in neonates during circumcision

• Hypersensitivity to amide-type local anesthetics or any component of the product

Avoid use with other topical anesthetics. No significant interactions with other drugs are known.

No food-related restrictions (topical application).

Pregnancy Category B: Limited safety data during pregnancy. Use only if clearly needed and under medical supervision.

[CONSULT YOUR DOCTOR] Excretion in breast milk is unknown. Use with caution in nursing mothers.

Pediatric dosing is weight-based (see dosage chart above). Maximum 1 hour for infants under 3 months or <5 kg.

No dose adjustment needed for elderly patients, but caution is advised.

Systemic absorption with topical application is minimal, but caution is advised in severe renal or hepatic impairment.

Overuse may cause systemic absorption and toxicity. Seek emergency medical attention if severe symptoms occur.

Store below 30°C, away from light and moisture. Keep out of reach of children.

Benzocaine + Butamben + Tetracaine