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  5. Label Information: Pain Relief 4% Lidocaine Dry Patch

FDA Label for Pain Relief 4% Lidocaine Dry Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNING
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST FEEDING
    9. KEEP OUT OF REACH OF CHILDREN AND PETS
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. PACKAGE / PRINCIPLE LABEL
    13. PACKAGE / INNER POUCH

Pain Relief 4% Lidocaine Dry Patch Product Label

The following document was submitted to the FDA by the labeler of this product Safrel Pharmaceuticals, 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



Lidocaine 4%


Purpose



Topical Anesthetic


Uses



Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.


Warning



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

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
  • 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



aluminum silicate, butylated hydroxytoluene, silicon dioxide, mineral oil, rosin, polyisobutylene (1000 mw), styrene/isoprene/styrene block copolymer, titanium dioxide, .alpha.-tocopherol acetate


* Please review the disclaimer below.