FDA Label for Pain Relief Patch Lidocaine

View Indications, Usage & Precautions

Pain Relief Patch Lidocaine Product Label

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



External analgesic


Uses



For temporary relief of pain


Warnings



For external use only


Do Not Use



over raw surfeces or blistered areas


When Using This Product



■ avoid contact with the eyes

■ do not use more than one patch on your body at a time


Stop Use And Ask A Doctor If



skin irritation develops
conditions worsen
symptoms persist for more than 7 days or 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 And Pets.



If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Directions



■ Adults and children 2 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 8 hour period. Maximum 3 patches per day. Discard patch after single use.

■Children under 2 years of age: Do not use, ask a doctor


Other Information



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


Inactive Ingredients



aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol


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