Perform Leo Extensive Pain Relief Patch
FDA Label NDC 84410-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Perform Leo Llc for the product Perform Leo Extensive Pain Relief (NDC 84410-001). 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 active ingredient                            purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                            Purpose

Lidocaine 4%                           Topical anesthetic

Menthol 1%                            Topical analgesic

Uses

For the temporary pain relief

Warnings

For external use only

Do not use

  • More than one patch at a time
  • On wounds or damaged skin
  • For more than one week without consulting a doctor
  • 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

      • Stop use and ask a doctor if :

      • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
      • conditions worsen
      • symptoms persist for more than 7 days
      • symptoms clear up and occur again within a few days

        • 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

Adult and Children 12 years of age and over

  • Clean and dry affected area
  • Remove film from patch and apply to the skin (see illustration)
  • Apply one patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

    • Children under 12 years of age: Consult a doctor

Other Information

  • Store at 68° - 77°F ( 20° - 25°C)
  • Store in a cool dry place away from direct sunlight

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)- Tartaric Acid, Mineral oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

Product Label

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