Lidocream 4
FDA Label NDC 52763-401

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 4 (NDC 52763-401). 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 4% W/W

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain and itching due to

  • minor burns
  • minor skin irritations
  • minor cuts
  • scrapes
  • sunburn
  • insect bites

Warnings

For external use only

When using this product

  • Avoid contact with the eyes 
  • Do not use in large quantities particularly over raw surfaces or blistered areas.
  • 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
    • notice any unusual effects such as blurred vision, dizziness or drowsiness, difficulty in breathing, trembling, chest pain or irregular heart beat

Directions

  • Adults and children 2 years and older: apply externally to the affected area not more than 3 to 4 times daily   
  • Children under 2 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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