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 March 7, 2019

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  • Active Ingredient

    L-Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • 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

    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 film 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

  • Other Information

    store at room temperature

  • Inactive ingredients

    dihydroxyaluminum aminoacetate, glycerol, kaolin, methylparaben, polyacrylic acid, propylene glycol, propylparaben, pvp, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

  • package label


    Pain Relief Medicated Patch

    carton

  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-1301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-1301-51 in 1 CARTON09/12/2011
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    TDS Pharm Co., Ltd.694894612manufacture(67510-1301)
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