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  5. Label Information: Perform Leo Extensive Pain Relief

FDA Label for Perform Leo Extensive Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT                            PURPOSE
    2. USES
    3. WARNINGS
    4. DIRECTIONS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. PRODUCT LABEL

Perform Leo Extensive Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Perform Leo Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



image description - Image 2

image description - Image 2


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