Active Ingredients
Lidocaine 4%
Menthol 1%
Healthwise Lidocaine And Menthol Patch
FDA Label NDC 71101-082
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Lidocaine And Menthol (NDC 71101-082). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Topical anesthetic
Topical analgesic
Use
for the temporary relief minor pain
Warnings
For external use only
Do Not Use
■ more than 1 patch on your body at a time
■ on a 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 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 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 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, free of lotions, oitments and creams.
■ Carefully remove backing from patch starting at a corner
■ Apply sticky side of patch to affected area
■ Maximum 2 patches per day.
■ Discard patch after single use
children under 12 years of age: consult a physician
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
* Please review the disclaimer below.
