Label: COLD AND HOT 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 August 1, 2012

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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
    • do not 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:

    • Remove backing from patch by grasping both ends firmly
    • 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

  • Other information

    store at room temperature
  • Inactive ingredients

    aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

  • package label


    Cold and Hot Pain Relief Patchimage of carton label

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-054-051 in 1 CARTON
    15 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2012
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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