Otc - Active Ingredient
Lidocaine 4%
Lidocaine Pain Relief Gel-patch
FDA Label NDC 87413-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Wankelai E-commerce Co., Ltd. for the product Lidocaine Pain Relief Gel-patch (NDC 87413-001). 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 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 wounds or damaged skin.
On puncture wounds.
For more than one week without consulting a doctore
lf pouch is damaged or opened.
lf your are allergic to any ingredients of this product.
Otc - When Using
Use only as directede
Read and follow all directions and warnings on this carton
Do not allow contact with the eyes
Do not use at the same time as other topical analgesicse
Do not bandage tightly or apply local heat (such asheating pads) to the area of use
Do not microwave
Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that canproduce serious adverse effects if a child or pet chews or ingests this patch.
Otc - Stop Use
Condition worsens
Redness is present
lrritation develops
Symptoms persist for more than 7 days or clear up andoccur again within a few days
You experience signs of skin injury, such as pain,swelling or blistering where the product was applied.
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison
Control Center right away.
Dosage & Administration
Adults and children 12 years of age and over:
Clean and dry the affected area.
Tear off the protective film and apply the exposed part of the patch to the affected area.
Carefully remove remaining film while pressing the patch firmly on the skin.Patch firmly on the skin.
Remove patch from the skin after at most 8-hour application.
Discard the patch after a 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, Urea, Water, Menthol
Aloe Vera, Vitamin E
Package Label.Principal Display Panel
Label (Label)
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