Lidocaine 5 Percent
FDA Label NDC 50488-6265

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Lidocaine 5 Percent (NDC 50488-6265). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a physician if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

For the temporary relief of local pain, soreness, burning, itching or discomfort associated with anorectal disorders.

Warnings

​For external use only.

When Using This Product

  • avoid contact with eyes
  • do not exceed recommended daily dosage unless directed by a physician
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a physician promptly

Stop Use And Ask A Physician If

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
  • if pregnant or breastfeeding

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a physician.

Other Information

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Juice), Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativus (Hemp) Seed Oil, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraguariensis (Yerba Mate) Extract, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Magnesium Sulfate, Phenoxyethanol, Polyacrylamide, Stearic Acid. 

Principal Display Panel

Lidocaine 5% Cream

NDC 50488-6265-1

​Lidocaine 5% 

Anorectal Cream

Topical Anesthetic

50 grams

Manufactured for: 

Alexso, Inc. 

Los Angeles, CA 90064

Principal Display Panellidocaine 5% Creamndc 50488-6265-1lidocaine 5% Anorectal Creamtopical Anesthetic50 Gramsmanufactured For: Alexso, Inc. Los Angeles, Ca 90064 (Lidocaine 5 Percent Cream 01)

Principal Display Panellidocaine 5% Creamndc 50488-6265-1lidocaine 5% Anorectal Creamtopical Anesthetic50 Gramsmanufactured For: Alexso, Inc. Los Angeles, Ca 90064 (Lidocaine 5 Percent Cream 01)

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