Active Ingredient
Menthol 3%
Capsaicin 0.083%
Pain Relief Hot Patch
FDA Label NDC 83559-016
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 Hot Patch (NDC 83559-016). 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, when using, stop use, ask doctor, 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 Analgesic
Use
Temporarily relieves minor pain associated with:
arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps
Warnings
EXTERNAL USE ONLY
When Using
• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.
Stop Use
STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present • skin irritation develops
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
Adults and Children 12 years of age and older:
• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
• Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: DO NOT use without consulting a doctor.
Other Information
For fast relief of minor aches and pains due to:
• Arthritis
• Strains
• Bruises
• Sprains
EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.
FAST-ACTING PAIN RELIEF
Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
MADE IN CHINA
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
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1 (Pack)
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