Label: WELLPATCH COOLING PAIN RELIEF- menthol patch

  • NDC Code(s): 10742-8125-1
  • Packager: The Mentholatum Company
  • 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 7, 2023

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  • Active ingredient

    Menthol 5%

  • Purpose

    Menthol - Topical Analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or to damaged or very sensitive skin
    • do not bandage tightly or use with a heating pad

    Stop use and ask a doctor if

    • condition worsens
    • excessive redness, irritation, burning, or discomfort of the skin develops
    • pain persists for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
    • children under 12 years: ask a doctor
    • FOR BEST RESULTS apply to clean, dry skin
    • tear open pouch and remove patch; if desired, cut patch to size
    • grasp both ends of the patch firmly with thumbs near center
    • stretch patch until the backing separates
    • remove protective film while applying patch directly to site of pain
  • Inactive ingredients

    carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

  • Questions?

    1-877-636-2677 MON - FRI 9AM to 5PM (EST)

    www.wellpatch.com

  • Package/Label Principal Display Panel

    WellPatch Cooling Pain Relief Patch
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    WELLPATCH COOLING PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8125-11 in 1 POUCH; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/06/2017
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8125)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mentholatum China Pharmaceuticals Co. Ltd.420786030manufacture(10742-8125)
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