Lidocaine Cream

The dose of Lidocaine and Tetracaine Cream that provides effective local dermal analgesia depends on the duration of the application. Although not specifically studied, a shorter duration of application may result in a less complete dermal analgesia or a shorter duration of adequate dermal analgesia.

• For use in adults only.
• Lidocaine and Tetracaine Cream should only be applied to intact skin.
• Lidocaine and Tetracaine Cream should not be applied to a procedure site after the procedure has been performed.
• Remove Lidocaine and Tetracaine Cream if skin irritation or a burning sensation occurs during application.
• In order to minimize the risk of systemic toxicity, do not exceed the recommended amount of drug to apply or the duration of the application [see Overdosage (10)] .
• Avoid eye and lip contact with Lidocaine and Tetracaine Cream.
• Wash hands after handling Lidocaine and Tetracaine Cream.
• Upon removal from the treatment site, discard the used Lidocaine and Tetracaine Cream in a location that is out of the reach of children and pets. Access to Lidocaine and Tetracaine Cream by children or pets should be prevented during usage and storage of the product [see Warnings and Precautions (5.2)] .
• Use only as directed

Lidocaine is an amide-type local anesthetic agent and tetracaine is an ester-type local anesthetic agent. Both lidocaine and tetracaine block sodium ion channels required for the initiation and conduction of neuronal impulses which, in certain instances, results in local anesthesia. When applied to intact skin, Lidocaine and Tetracaine Cream provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.

Lidocaine and Tetracaine Cream is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, local anesthetics of the amide or ester type, or to any other component of the product [ see Warnings and Precautions (5.4)]. Lidocaine and Tetracaine Cream is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity.

The following adverse reactions are described elsewhere in the labeling:

• Methemoglobinemia [see Warnings and Precautions (5.1)]
• Overexposure [see Warnings and Precautions (5.2)]
• Risks of Secondary Exposure in Children and Pets [see Warnings and Precautions 5.3)]
• Anaphylactic Reactions [see Warnings and Precautions (5.4)]

Room Temperature