Otc - Active Ingredient
Lidocaine 4%
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zhupuyou E-commerce Co., Ltd for the product Lidocaine Pain Relief Gel-patch (NDC 84165-005). 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.
Lidocaine 4%
Topical Anesthetic
Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shouldcrs,elbows.
For external use only
· more than 1 patch on your body at a time or with other topical anesthetics at the same time
· on wounds or damaged skin
· with a heating pad or device
· with other ointments, creams, sprays, or liniments
· if you are allergic to any ingredients of this product
· use only as directed
· avoid contact with the eyes, mucous membranes, or rashes
· do not bandage tightly
· dispose of used patch in manner that always keeps product away from 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.
· localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
· condition worsens
· symptoms persist for more than 7 days
· symptoms clear up and occur again within a few days
if swallowed accidentally , get medical help orcontact with Poison Control Center immediately.
Adults and Children above 12 years old:
· 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.
· Apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
· Remove patch from the skin after at most 8-hour application
Children under age of 12:Consult a doctor
Dihydroxyaluminum Aminoacetate Anhydrous
Glycerin
Kaolin
Methylparaben
Polyacrylic Acid
Polysorbate 80
Propylene Glycol
Propylparaben
PVP
Sodium Polyacrylate
Tartaric Acid
Titanium Dioxide
Water
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