Microcaine Topical Analgesic Cream
FDA Label NDC 67194-022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose, Ltd. for the product Microcaine Topical Analgesic (NDC 67194-022). 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 drug facts, active ingredient, purpose, uses:, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain from anorectal origin.

Warnings

For External Use only

When Using This Product

  • Do not get into the eyes
  • Do not use more than directed
  • Do not swallow

Stop Use And Ask A Doctor If

  • pain worsens or does not improve within 7 days or clears up and appears again in a few days
  • ​you develop an allergy

Keep Out Of Reach Of Children

  • If swallowed, get medical help right away or contact a Poison Control Center right away. NDC 67194-022-01

Directions:

​Children under 12 years-ask a doctor

  • Adults: Apply 1-2 gm to desired area and wait 12 to 60 minutes. Remove excess. May repeat 2-3 times/day.

Questions?

​Call toll free 888/452-4946

Inactive Ingredients:

Water (Aqua), Prolatum Oil. Stearyl Alcohol, Polysorbate 60, Cetearyl Alcohol, Glyceryl Stearate, Carbomer, Triethanolamine, Propylparaben, Propylene Glycol, Methylparaben, Disodium EDTA, Diazolidinyl Carbamide, BHT

​Package Labeling:

Mcaine2 (Mcaine2)

Mcaine2 (Mcaine2)

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