LMX5 (Lidocaine 5%) Topical Anorectal Cream

LMX5 is an over-the-counter (OTC) topical anesthetic cream whose active ingredient is lidocaine 5% (w/w). The FDA-approved label (DailyMed) describes its purpose as a local anesthetic that “temporarily relieves pain and itching due to anorectal disorders.” In other words, it’s used to numb and reduce discomfort from conditions like hemorrhoids or anal fissures. The product is packaged by Ferndale Laboratories and explicitly listed as a “Human OTC drug” on the label, meaning it can be purchased without a prescription.

Directions for Use

• Clean and dry the area first. Gently wash the affected area with mild soap and warm water, then pat it dry with toilet tissue or a soft cloth.
• Apply the cream. Adults and children 12 years or older: apply a thin layer of LMX5 to the affected area up to 6 times per day. Children under 12 should use this product only on a doctor’s advice.

Warnings & Precautions

• Avoid contact with eyes. If LMX5 gets into the eyes, rinse them thoroughly with water. Do not apply the cream to your eyes or mouth.
• Follow dosage instructions. Do not exceed the recommended amount or frequency.
• When to stop and seek help. Discontinue use and consult a doctor if any of the following occur: rectal bleeding; the condition worsens or does not improve within 7 days; or an allergic-type reaction develops (signs include rash, redness, swelling, increased pain or itching). Also stop use if symptoms improve but then return shortly after.
• Keep out of reach of children. Store the product safely. If a child swallows LMX5, get medical help or contact a Poison Control Center right away.
• Other precautions. Use only as directed on the anus/rectum; do not apply to large areas of the body or broken skin. Consult a doctor before use if you are pregnant, nursing, or have liver disease (since lidocaine is metabolized in the liver, caution is advised).

Additional Information

• Storage: Store at room temperature, about 25 °C (77 °F). Brief excursions between 15 – 30 °C (59 – 86 °F) are permitted.
• Inactive ingredients: The cream contains benzyl alcohol, carbomer, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, water, trolamine, and vitamin E acetate (for formulation stability).

Disclaimer: This summary is based on the official FDA label for LMX5. It is for informational purposes and not a substitute for professional medical advice. Always read the product label and consult a healthcare provider with any questions or concerns.