Active Ingredient
Camphor 80mg
Menthol 24mg
Capsicum Extract 16mg
Pain Relief Patch
FDA Label NDC 83559-005
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 Pain Relief Patch (NDC 83559-005). 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 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
For temporary relief of pains
Warnings
For external use only
Do Not Use
·Do not get into eyes or on mucous membranes
·Do not apply to wounds, damaged or irritated skin
·Do not bandage or cover with any type of wrap except clothing
·Do not use with a heating pad or apply external heat
·Do not use 1 hour prior to bathing or within 30 minutes after bathing
When Using
·Use only as directed
Stop Use
·Condition worsens
·Severe skin irritation occurs
·Pain persists for more than 7 days
·Symptoms clear up and occur again within a few days
Ask Doctor
If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.
Children under 12 years, consult doctor before use
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away.
Directions
·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
·Children under 12 years, consult doctor before use
How to apply:
·Clean and dry affected area
·Cut open pouch and remove patch
·Remove protective film and apply directly to area of pain
·Apply to affected area not more than 3 times daily
·Wash hands with soap after applying patch
·Reseal pouch containing unused patches
Other Information
This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.
Inactive Ingredients
Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, Water
Questions
1-800-910-6874
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