Label: COLD AND HOT MEDICATED PAIN RELIEF LARGE- 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

    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 with heating pad
    • avoid contact with eyes and mucous membranes
    • 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 immediately.

  • 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 under 12 years of age: Ask a doctor

  • Inactive ingredients

    dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polyethylene glycol 400, polysorbate 80, povidone, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

  • Questions or Comments?

    call 1-800-883-0085

    Reseal pouch after opening

  • package label


    Best Choice Cold and Hot Large Medicated Patch

    carton

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED PAIN RELIEF LARGE 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-949
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL875 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POVIDONE (UNII: FZ989GH94E)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-949-051 in 1 CARTON12/29/2018
    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 - Valu Merchandisers Company, Inc. (868703513)
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