Active Ingredient
Lidocaine 4.0%
Zytherial Lidocaine 4% Pain Relief Patch
FDA Label NDC 87786-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenzhou Yuyuan Pharmaceutical Co., Ltd. for the product Zytherial Lidocaine 4% Pain Relief Patch (NDC 87786-024). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
Temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.
Warnings
For external use only
Do Not Use
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product
• More than one patch at a time unless directed by a healthcare professional
When Using
• Use only as directed
• Avoid contact with eyes
• Do not bandage tightly
• Do not use with other topical pain-relief products
• Stop use if excessive irritation occurs
Stop Use
·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
Ask Doctor
·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
If pregnant or breastfeeding： Ask a healthcare professional
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Do not use if pouch is open or damaged.
Directions
Adults and children 12 years and over:
·Clean and dry affected area
·Remove protective film
·Apply to affected area
·Remove after at most 12 hours
·Remove patch after use
Children under 12 years:
·Consult a healthcare professional before use.
Other Information
• Store at room temperature
• Protect from excessive heat and moisture
• Reseal pouch after opening
Inactive Ingredients
Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Polyacrylic Acid, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Principal Display Panel
4 (F3e30fdb08ad90a4f8a853bce19d2bb3)
* Please review the disclaimer below.
