Lidfix Pain Relief Patch Lidocaine Patch
FDA Label NDC 87497-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hetero Healthcare Limited for the product Lidfix Pain Relief Patch Lidocaine (NDC 87497-001). 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, 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 anesthetic

Uses

For temporary relief of minor pain

Warnings

(For external use only)

Do Not Use:

  •  More than one patch at a time
  •  On wounds or damaged skin
  •  With a heating pad
  •  If you are allergic to any ingredients of this product

When Using This Product

  •  Use only as directed
  •  Avoid contact with the eyes, mucous membranes or rashes
  •  Do not bandage tightly
  •  Do not use this product immediately after bath or shower

Stop Use And Ask A Doctor If:

  •  Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  •  Condition worsens
  •  Symptoms persist for more than 7 days
  •  Symptoms clear up and occur again within a few days
  •  Do not use with other topical analgesics
  •  Keep children and pets away from used or disposed patch
  •  Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product

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 of age and over:

  •  Clean and dry affected area
  •  Remove film from patch and apply to the skin
  •  Use only one patch at a time for up to 12 hours

    • Children under 12 years of age: Consult a doctor

Other Information

  • Avoid storing product in direct sunlight, Store at room temperature 20°C-25°C, Do not exceed 30°C.
  •  Protect product from excessive moisture

Inactive Ingredients

Styrene Isoprene Styrene Block Copolymer, Alicyclic Saturated Hydrocarbon Resin, Butylated HydroxyToluene, Isopropyl Myristate, Oleic Acid, Propylene Glycol, White Mineral Oil

Questions?

Call: 1800 103 4696

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