Other
Lidocaine Patch
Lidocaine Patch
FDA Label NDC 84023-601
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 Yangan Technology Co., Ltd. for the product Lidocaine Patch (NDC 84023-601). 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
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
On puncture wounds
For more than one week without consulting a doctor
lf you are allergic to 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 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, Used patches 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 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 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 patchto affected area. Use one patch for up to 12 hours. Discard patch aftersingleuse.Children under 12 years of age: consult a physician.
Storage And Handling
Store in a clean, dry place outside of direct sunlight. Protect product form
excessive moisture.
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
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Label (Label)
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