Active Ingredient
Menthol 5%
Cold And Hot Medicated Patch
FDA Label NDC 83559-014
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 Cold And Hot Medicated Patch (NDC 83559-014). 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 relieve minor pain associated with:
• arthritis • simple backache • muscle strains • bursitis • tendonitis • strains • bruises • cramps
Warnings
For external use only.
When Using
When using this product • 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:
• peel off protective backing and apply sticky side to affected area
• carefully remove backing from patch
• should be used up to 8 hours
• should be used no more than 3 to 4 times daily
• children under 12 years of age: consult a doctor
Other Information
• store at room temperature 68° to 77°F (20° to 25°C)
Compare to the active ingredient in Icy Hot® Patch
EXTRA STRENGTH
Contains Menthol 5%
Works on contact for cooling pain relief
Pain relieving ointment on a breathable adhesive pad
*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Icy Hot® Patch.
Distributed by:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
MADE IN CHINA
www.universaldc.com
Inactive Ingredients
Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Questions
www.universaldc.com
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