Lidocaine 4 Percent Cream
FDA Label NDC 69420-6262

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sa3, Llc for the product Lidocaine 4 Percent (NDC 69420-6262). 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, when using this product, stop use and ask a doctor, 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

Active Ingredient

Lidocaine HCl 4% w/w

Purpose

Topical Analgesic

Uses

Temporarily relieves pain and itching due to:

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

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

Stop Use And Ask A Doctor

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • If allergic reaction occurs or if redness, irritation, swelling, pain or other symptoms begin or increase.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other Information

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Principal Display Panel

Lidocaine HCl 4% cream

NDC 69420-6262-1 

Topical Analgesic Cream

4.2 OZ (120 g)

SA3, LLC

Tabledescription Automatically Generated (Lidocaine 4 Percent Cream 01)

Tabledescription Automatically Generated (Lidocaine 4 Percent Cream 01)

* Please review the disclaimer below.