Label: COLD AND HOT MEDICATED- menthol patch

  • NDC Code(s): 10742-8117-1, 10742-8117-2
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Menthol 5%

    Close
  • Purpose

    Menthol - Topical analgesic

    Close
  • Uses

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

    arthritis
    simple backache
    strains
    sprains
    bursitis
    tendonitis
    bruises
    cramps
    Close
  • Warnings

    When using this product

    use only as directed
    avoid contact with eyes or on 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

    excessive redness or irritation is present
    condition worsens
    pain persist for more than 7 days
    symptoms clear up and occur again within a few days

    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.

    Close
  • Directions

    adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
    children under 12 years: ask a doctor
    for easy application; grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.
    Close
  • Inactive ingredients

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

    Close
  • Package/Label Principal Display Panel

    Cold and Hot Medicated Patch Menthol 5% (Large)

    Cold and Hot Medicated Patch Menthol 5% Large
    Close
  • Package/Label Principal Display Panel

    Cold and Hot Medicated Patch Menthol 5% (Small)

    Cold and Hot Medicated Patch Menthol 5% Small
    Close
  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8117
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM  
    DIHYDROXYALUMINUM AMINOACETATE  
    EDETATE DISODIUM  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    POLYVINYL ALCOHOL  
    POLYACRYLIC ACID (250000 MW)  
    POLYSORBATE 80  
    WATER  
    SORBITAN SESQUIOLEATE  
    SORBITOL  
    TALC  
    TARTARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8117-1 5 in 1 POUCH
    2 NDC:10742-8117-2 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/10/2008
    Labeler - The Mentholatum Company (002105757)
    Close