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  5. Label Information: Lidocaine And Menthol

FDA Label for Lidocaine And Menthol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH PATCH)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS
    7. STOP USE AND CONSULT A DOCTOR IF
    8. IF PREGNANT OR BREASTFEEDING,
    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

Lidocaine And Menthol Product Label

The following document was submitted to the FDA by the labeler of this product Marcella Health. 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 Ingredients (In Each Patch)



Lidocaine 4%

Menthol 1%


Purpose



External Anesthetic

External Analgesic


Use



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 This



  • use only as directed 
  • read and follow all directions and warnings on this carton 
  • do not allow contact with the 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 Consult 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 Breastfeeding,



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 1-800-222-1222 right away.


Directions



Adults and children 12 years of age and over:clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. 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



dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water


Questions Or Comments?



Call (307) 410-3813 or email [email protected]


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