Walgreens Lidocaine Back Patch
FDA Label NDC 0363-2178

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Lidocaine Back (NDC 0363-2178). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, 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 4%

Purpose

Topical Analgesic

Use

For temporary relief of pain

Warnings

For external use only

Do Not Use

  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients 
  • If pouch is damaged or opened

When Using This Product

  • Use only as directed
  • Read and follow all directions and warnings
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical anesthetics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Ask A Doctor If

  • condition worsen 
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children 12 years if age and over:

  • Clean and dry affected area
  • Carefully remove backing from patch
  • Apply sticky side of patch to affected area
  • Use one patch for up to 8 hours
  • Discard patch after single use
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily

    • Children under 12 years of age:consult a physician.

Other Information

  • Store in a clean, dry place outside of direct sunlight
  • Protect from excessive moisture

Inactive Ingredients

A-tocopherol Acetate, CMC-2Na, Dihydroxyaluminum Aminoacetate, Fumed Silica, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Vanillyl Butyl Ether, Water, 3-2-(Ethylhexyl)oxyl-1, 2-Propanediol.

Package Labelling:

Label.jpg (Label)

Label.jpg (Label)

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