Otc - Active Ingredient
Menthol 5%
Capsaicin 0.25%.
Menthol Pain Relief Patches Patch
FDA Label NDC 84876-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menthol Pain Relief Patch for the product Menthol Pain Relief Patches (NDC 84876-005). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:simple backache, arthritis
,strains,bruises,sprains
Warnings
WarningsFor externaluse only.
Otc - When Using
use only as directed avoid contact with the eyes or on mucous membranes
do not apply to wounds or damaged skin
do not apply to irritated skin or if excessive irritation
do not bandage tightly or use with heating pad or device
Otc - Stop Use
you experience pain, swelling or blistering of the skinicondition worsens, or if symptoms persist for more than 7 days or clear up and occuragain within afew daysarthritic pain persists for more than 10 days, or redness is present
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lfswallowed, get medical help or contact a Poison ControlCenter right away.
Indications & Usage
i adults and children 12 years of age and older: Clean and dry affected area, pop apartand partiallypeel back protective film and apply exposed patch to site of pain. Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily.children under 12 years of age: consult a physicianwash hands after use with cool water
Dosage & Administration
Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily
Inactive Ingredient
Inactive ingredients
Sodium polyacrylate,Aluminium glycinat,Disodium edetate dihydrate,Purified water,Tartaric acid ,polyving alcohol,Glucosamine,gl ycerol.
Package Label.Principal Display Panel
Labeling (84876 005 01)
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