Other
Lidocaine Pain Relief Patch
Lidocaine Pain Relief Patch
FDA Label NDC 84664-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shijiazhuang Mykang Trading Co., Ltd. for the product Lidocaine Pain Relief Patch (NDC 84664-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine 4%
Otc - Purpose
Topical Anesthetic
Indications & Usage
For the temporary relief of pain.
Warnings
For external use only.
Otc - Do Not Use
Do not use more than 1 patch at a time on wounds or damagedskin with a heating pad lf you are allergic to any ingredients ofthis product
Otc - When Using
Avoid contact with the eyes When using this product
Otc - Stop Use
Stop use and ask a doctor if localized skin reactions occur,such as rash, itching, redness, irritation condition worsens, or if symptoms persist for more than 7 days or clear up and occur againwithin a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Centerright away.
If pregnant or breast-feeding, ask a health professional before use
Dosage & Administration
Adults and children 12 years of age and older:
Clean and dry the affected area
Apply a patch at a time to the affected area; not more than 3 or 4times daily to the affected area
Remove the patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a doctor.
Storage And Handling
Store at 20-25°C(68-77°F)and protect from moisture.
Inactive Ingredient
dihydroxyaluminium aminoacetate
disodium EDTA
Methylparaben
polyvinyl alcohol
propylene glycol
sodium carboxymethyl cellulose
sodium polyacrylate
propyl paraben
titanium dioxide
tartaric acid
Glycerin
purified water
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Label (Label)
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