Lidocaine 5% Cream
FDA Label NDC 82461-420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcore Llc for the product Lidocaine 5% Cream (NDC 82461-420). 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, keep out of reach of children., directions, other information, inactive ingredients, 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 doctor promptly

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 doctor.

Other Information

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

Stearic Acid,Magnesium Sulfate Unspecified, Laureth,Isopropyl Myristate,C13-14 Isoprraffin, Sunflower Oil,Glycyrrhiza Glabra,Paraguay holly extract,Phenoxyethanol,Glyceryl-Steatate, Polyacrylamide,Lemon oil,Water,Peppermint oil.

Stop Use And Ask A Doctor 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

Manufactured For:

Medcore LLC 3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Principal Display Panel

NDC: 82461-420-30

Lidocaine 5%
Topical Anesthetic Anorectal Cream

Medcore LLC

30 gram

Lidocaine (Lidocaine 01)

Lidocaine (Lidocaine 01)

Lidocaine (Lidocaine 02)

Lidocaine (Lidocaine 02)

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