Active Ingredient
Lidocaine 4%
Kocowo Lidocaine Pain Relief Gel-patch
FDA Label NDC 83559-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Enokon Medical Instrument Co., Ltd. for the product Kocowo Lidocaine Pain Relief Gel-patch (NDC 83559-010). 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 anesthetic
Use
Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.
Warnings
For external use only
Do Not Use
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
When Using
use only as directed
avoid contact with the eyes, mucous membranes or rashes
do not bandage tightly
Stop Use
Stop use and ask a doctor if
skin reactions such as redness, swelling, blistering or other discomfort occur.
symptoms persist for more than 7 days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Children under age of 12: Consult a doctor
Keep Out Of Reach Of Children
If swallowed accidentally, get medical help or contact with Poison Control Center immediately.
Directions
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 the affected area.
Carefully remove remaining film while pressing the patch firmly on the skin.
Remove patch from the skin after at most 8-hour application.
Inactive Ingredients
Glycerin,Sodium polyacrylate,Polyvinyl pyrrolidone,Phenoxyethanol,Tartaric Acid,Ethyl ethyl glycerol,Sodium carboxymethyl cellulose,Aluminum Glycinate,Styrene acrylic copolymer emulsion,EDTA,Titanium Dioxide,Polysorbate 80,Sorbitol,Purified Water
Principal Display Panel
1 (Label)
* Please review the disclaimer below.
