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  5. Label Information: Welmate Lidocaine Pain Relieving Patch

FDA Label for Welmate Lidocaine Pain Relieving Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    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. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Welmate Lidocaine Pain Relieving Patch Product Label

The following document was submitted to the FDA by the labeler of this product Yyba Corporation. 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



For temporary 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 This Product



  • use only as directed
  • read and follow directions 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 use
  • Do not microwave
  • Dispose of used patch in manner that always keeps product away from children 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 Ask A Doctor If



  • conditions worsen
  • 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 800-222-1222 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 12 hours.
  • Discard patch after single use

    • Children under 12 years of age: consult a physician


Other Information



  • Store in a clean, dry place outside of direct sunlight
  • Protect from excessive moisture

Inactive Ingredients



aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol


Questions Or Comments?



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