Otc - Active Ingredient
Lidocaine 4%
Lidocaine Patch
FDA Label NDC 85839-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Finona Information Technology Co., Ltd for the product Lidocaine Patch (NDC 85839-007). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Anesthetic
Indications & Usage
Temporarily relieves minor pain
Warnings
For external use only
Otc - Do Not Use
More than one patch on your body at a time On cut, initated or swollen skin Onpuncture wounds. For more than one week without consulting a doctor lf you are allergicto any active or inactive ingredients lf pouch is damaged or opened.
Otc - When Using
When using this product Use only as directed Read and follow alldirections and waringson this carton Do not allow contact with the eyes. Do not use at the same time as othertopical analgesics Do not bandage tightly orapply local heat (such as heating pads) to thearea of use Dispose of usedpatch inmanner that always keeps product away from childrenand pets, Used patches stil contain the drug product that can produce serious adverse effectsifa child or pet chews or ingests this patch.
Otc - Stop Use
Stop use and consult a doctor if, Condition worsens,Redness is present lrritationdevelops Symptoms persist for more than 7 days or clear up and occur again within afew days You experience signs of skin injury, such as pain, swelling or blistering wherethe product was applied.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets
Dosage & Administration
Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area.Use one patch for up to 12 hours. Discard patch aftersingleuse.
Children under 12 years of age: consult a physician.
Inactive Ingredient
Aluminum Glycinate
Aluminum Hydroxide
Cellulose Gum
DMDM hydantoin
Glycerin
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Ricinus Communis Seed Oil (castor)
Silica
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Urea
Water
Package Label.Principal Display Panel
Label7 (Label7)
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