Menthol + Pramoxine Hydrochloride

Pain and Itching: For temporary relief of pain and itch associated with minor skin irritations, minor cuts, minor burns, minor sunburns, scrapes, or insect bites; may also be used for rashes due to poison ivy, oak, or sumac.

Menthol primarily activates the cold-sensitive TRPM8 receptors in the skin. Menthol, after topical application, causes a feeling of coolness due to stimulation of 'cold' receptors by inhibiting Ca++ currents of neuronal membranes. It may also yield analgesic properties via kappa-opioid receptor agonism.

Pramocaine reversibly binds and inhibits voltage gated sodium channels on neurons decreasing sodium permeability into the cell. This stabilizes the membrane and prevents ionic fluctuations needed for depolarization stopping any action potential propagation.

Menthol and pramoxine: Each of these agents elicits local anesthetic effects.

Adult: Apply topically to affected area up to 3-4 times daily.

Child:

• <2 years: Safety and efficacy not established
• >2 years: Apply topically to affected area up to 3-4 times daily

There are no known drug interactions and none well documented.

Hypersensitivity, Deep or puncture wounds, animals bites, serious burns, large areas of the body.

Redness, irritation, swelling or pain.

Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

For external use only. Avoid contact with eyes Do not use in the eyes or mucous membranes Not for prolonged use Do not apply to large areas of the body. Discontinue if symptoms persist for >7 days or clear up and occur again within a few days. Discontinue if redness, irritation, swelling, or pain persists or increases.

Local Antipruritic, Topical Analgesics.