Active Ingredient(S)
Lidocaine 4.0%
Lidocainepain Pain Reliving Gel-patch
FDA Label NDC 84291-004
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 Yuetai Electronic Commerce Co., Ltd for the product Lidocainepain Pain Reliving Gel-patch (NDC 84291-004). 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(s), purpose, use, warnings, 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
Purpose
Topical anesthetic
Use
Temporarily relieves muscle soreness and minor joint pain
Warnings
For external use only
Do Not Use
■On cut, irritated, or swollen skin ■ With a heating pad or device
■If you are allergic to any active or inactive ingredients in this product
■For more than one week without consulting a doctor ■More than one patch at a time
■If the pouch is damaged or opened
Otc - When Using
Use only as directed
Do not bandage tightly
Do not microwave
Avoid contact with eyes, mucous membranes, or rashes
Otc - Stop Use
Your condition worsens
Localized skin reactions such as rash,itching, redness, swelling,or blistering occur
Symptoms persist for more than 7 days or clear up and then return within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children 12 years of age and older:
■ Clean and dry the affected area
■ Do not use more than 3 to 4 patches daily
■ Carefully peel off the protective film, starting from one corner
■ Apply the sticky side of the patch to the affected area and press firmly to ensure adhesion
■ Use only one patch at a time
■ Leave on for up to 8 to 12 hours
■ Discard the patch after a single use
Children under 12 years of age:Consult a physician
Other Information
Store in a clean, dry place away from direct sunlight.
Do not store at temperatures above 30°C (86°F).
Protect from excessive moisture..
Inactive Ingredients
Water, Glycerin, Propylene Glycol, Sodium Polyacrylate, Polyvinyl Alcohol, Tartaric Acid
Package Label - Principal Display Panel
Undefined (Label26)
Undefined (Label15)
Undefined (Label10)
Undefined (Label25)
Undefined (Label34)
Undefined (Label20)
Undefined (Label30)
* Please review the disclaimer below.
