WELLPATCH COOLING PAIN RELIEF (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]

WELLPATCH COOLING PAIN RELIEF (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]
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NDC 10742-8125-1
Set ID 13565b05-ce32-444c-8765-cda23b0036fc
Category HUMAN OTC DRUG LABEL
Packager The Mentholatum Company
Generic Name
Product Class
Product Number
Application Number PART348
  • 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)

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