Otc - Active Ingredient
Lidocaine 4%
4% Lidocaine Maximum Strength Pain Relief Patch
FDA Label NDC 85839-011
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 4% Lidocaine Maximum Strength Pain Relief (NDC 85839-011). 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
Use Temporarily relieves minor paln.
Warnings
For external use only
Otc - Do Not Use
Do not use More than one patch on your body at a time On cut, initated orswollen skin On puncture wounds For more than one week without consultinga doctor lf you are allergic to any active or inactive ingredients lf pouch isdamaged or opened.
Otc - When Using
When using this product Use only as directed Read and follow alldirections and warings 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 orapply local heat (such as heating pads) to the area of use Dispose of usedpatch inmanner that always keeps product away from children and pets. Usedpatches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.
Otc - Stop Use
Stop use and consult a doctor if Condition worsens Redness is presentlrritation 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.
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 patch to affected area. Use one patch for up to 12 hours. Discard patch aftersingle use.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
Label (Label)
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