Active Ingredient
Menthol 5% ...... Purpose: Topical analgesic
Pain Relief Patch
FDA Label NDC 73557-192
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. for the product Pain Relief (NDC 73557-192). 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, uses, warnings, ask doctor, when using, do not use, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthrits
- strains
- bruises
- sprains
Warnings
For external use only
Ask Doctor
Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present
If pregnant or breastfeeding,ask a health professional before use.
When Using
When using this prudocts:
• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
Do Not Use
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
Stop Use
Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present
Pregnancy Or Breast Feeding
If pregnant or breastfeeding,ask a health professional before use.
Keep Out Of Reach Of Children
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions
• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.
•
children under 12 years of age: consult a physician
• wash hands after use with cool water
Inactive Ingredients
Benzalkonium Chloride,Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin,Kaolin,Lauralkonium Chloride,Lavender Oil, Mineral Oil,Petrolatum, Polyacrylic Acid,Polysorbate 80, Propylene Glycol, Povidone K90,Sodium Polyacrylate,Tartaric Acid,Titanium Dioxide,Water
Questions Or Comments
Other Information
• store at 68-77℉ (20-25℃)
• store in a cool dry place away from direct sunlight
Package Label. Principal Display Panel
Patch (192 Patch)
192-05 (73557 192 05)
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