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  5. Label Information: Manamed Lidocaine 4% Pain Relieving Gel Patch

FDA Label for Manamed Lidocaine 4% Pain Relieving Gel Patch

View Indications, Usage & Precautions

Table of Contents

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

Manamed Lidocaine 4% Pain Relieving Gel Patch Product Label

The following document was submitted to the FDA by the labeler of this product Manamed, Inc.. 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



Lidocaine 4%


Purpose



Topical Anesthetic


Uses



Temporarily relieves minor 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 is product

    • Use only as direacted
    • Read and follow all direactions and warnings on this carton
    • Do not allow contact with eyes
    • Do not use at the same time as other topical analgesics
    • Do not bandage tightly or apply local heat (such as heating pads)to the area of the use
    • Do not microwave
    • Dispose of used patch in the manner that always keeps product away from childen 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 consult a doctor if

      • Condition worsens
      • Redness is present
      • Irritation develops
      • Symtoms persists 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 breastfeading, ask 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 12 years of age and over:

Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.Use one patch for up to 8 hrs

Children under 12 years of age : consult a physician


Other Information



Store in clean, dry place outside of direact sunlight. Protect from excessive moisture.


Inactive Ingredients



Water, Glycerin, Propylene Glycol, PVP, Sodium Polyacrylate, Methylparaben, Propylparaben, Aluminum Glycinate, Kaolin, Polyacrylic Acid, Polysorbate 80, Tartaric Acid, Titanium Dioxide


Product Label



image description - Image 1

image description - Image 1


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