Label: MEDICATED PAIN RELIEF- menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 17, 2023

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  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • muscle strains
    • simple backache
    • bursitis
    • cramps
    • tendonitis
    • muscle sprains
    • bruises
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use a heating pad
    • avoid contact with eyes and mucous membrane
    • do not apply to wounds or damaged skin
    • do not use if you are allergic to any ingredients of this product

    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
    • irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children over 12 years:

    Carefully remove backing from patch

    Apply one patch to affected area

    Repeat as necessary, but no more than 4 times daily.

    Children 12 years or younger:

    ask a doctor

  • Inactive ingredients

    aluminium glycinate, 1,3-butylene glycol, carboxymethyl cellulose sodium, concentrated glycerin, diethylene glycomonoethyl ether, disodium edetate, methyl parahydroxybenozate, polyacrylic acid solution, polysorbate 90, propyl parahydroxybenzoate, purified water, sodium polyacrylate, tartaric acid, titanium oxide

  • package label


    Pain Relief Medicated Patch

    carton

  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL428.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0301-51 in 1 CARTON12/01/2011
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/12/2011
    Labeler - Kareway Product, Inc. (121840057)
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