Active Ingredient
Capsicum Extract Capsaicin 0.025%
Capsaicin Heat Patch
FDA Label NDC 83559-013
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 Capsaicin Heat Patch (NDC 83559-013). 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 minor aches and pains of muscles & joints associated with:
• Simple Backache • Arthritis • Strains • Bruises • Sprains
Warnings
EXTERNAL USE ONLY
Do Not Use
• on wounds or damaged skin
• with a heating pad
• with or at the same times as other external analgesic
• if you are allergic to any ingredients of this product
When Using
• do not use otherwise than as directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower
Stop Use
• rash, itching or excessive skin irritation develops
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within few days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: Consult a doctor.
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 over:
Clean and dry affected area
Remove patch from film
Apply to affected area not more than 3 to 4 times daily
Remove patch from skin after at most 8 hours of application
Other Information
• Avoid storing product in direct sunlight
• Protect product from excessive moisture
Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®
*This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.
Distributed By:
Universal Distribution Center
96 Distribution Boulevard • Edison, NJ 08817
MADE IN CHINA
www.universaldc.com
Inactive Ingredients
camphor, eucalyptus oil, lanolin, peppermint oil, menthol, methyl salicylate, styrene/isoprene copolymer, zinc oxide
Questions
www.universaldc.com
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1 (Pack)
2 (Pack2)
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