Sonacaine Topical Anesthetic With Menthol Gel
FDA Label NDC 62221-935

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filltech Usa, Llc for the product Sonacaine Topical Anesthetic With Menthol (NDC 62221-935). 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 sonacaine topical anesthetic gel with menthol, drug facts, active ingredients, purpose, uses:, warnings:, 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

Sonacaine Topical Anesthetic Gel With Menthol


Drug Facts


Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses:

temporary relieves pain and itching due to:

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

Warnings:

For external use only.

Keep Out Of Reach Of Children


Directions:

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Sonacaine Topical Anesthetic Gel With Menthol 2Oz/60G (62221-935-02)

Sonacaine (Sonacaine)

Sonacaine (Sonacaine)

* Please review the disclaimer below.