Otc - Active Ingredient
Lidocaine 4%
4% Lidocaine Pain Relief Patch
FDA Label NDC 87278-020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangxi Keyun E-commerce Co., Ltd. for the product 4% Lidocaine Pain Relief Patch (NDC 87278-020). 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
Do not use More than one patch on your body at a time On cut, irritated or swollen skin Onpuncture wounds For more than one week without consulting a doctor If you are allergic to
any active or inactive ingredientsin this product
Otc - When Using
When using this product Use only as directed Read and follow all directions and warningson this carton Do not allow contact with theeyes Do not use other topical analgesics Donot bandage tightly or use with a heating pad Discontinue use and consult a doctor if painpersists or if redness is present Avoid intense physical activities that increase sweating as itmay cause patch to come off or increase skin irritation Keep out of reach of 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.
Otc - Stop Use
Stop use and consult a doctor if Condition worsens Redness is present Irritation devel-ops. Symptoms persist for more than 7 days or clear up and occur again within a few daysYou experience signs of skin injury, suchas 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 patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single 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
Water
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Label (Label)
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