Maximum Strength 4% Lidocaine Patch
FDA Label NDC 71811-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Intermed Laboratories Private Limited for the product Maximum Strength 4% Lidocaine Patch (NDC 71811-004). 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, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
  • over raw surfaces or blistered areas
  • uif 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 on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or 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 worsens
  • 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 And Pets

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

Directions

Adults and children over 12 years:

  • clean and dry affected area free of lotions, ointments and creams.
  • carefully remove backing from patch starting at a corner. Apply sticky side of patch ti affected area.
  • Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discar patch after single use.

    • children 12 years or younger:ask a physician.

    Adults and children over 12 years:

    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch for up to 12 hours

      • children 12 years or younger:ask a doctor

Inactive Ingredients

dihydroxy aluminium aminoacetate, disodium EDTA, glycerin, methyl paraben, polyvinyl alcohol, propyl paraben, propylene glycol, sodium carboxy methyl cellulose, sodium polyacrylate, tartaric acid, titanium dioxide, water

Bulk Package Label

Lid (Lid)

Lid (Lid)

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