Lidocream 5
FDA Label NDC 52763-502

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Golden Touch Llc for the product Lidocream 5 (NDC 52763-502). 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, directions, inactive ingredients, packaging, 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 pain and itching due to anorectal disorders

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not put in rectum
  • Do not exceed recommended dosage unless directed by a doctor


    • Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days  
    • Symptoms clear up and return within a few days
    • rectal bleeding occurs
    • redness irritation, swelling, pain or other symptoms develop or increase

Directions

  • Adults 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
  • Apply externally to the affected area up to 6 times daily.
  • Children under 12 years of age: consult a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

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