Label: COLD AND HOT PAIN RELIEF- menthol patch

  • NDC Code(s): 67510-0300-2, 67510-0300-3, 67510-0300-4, 67510-0300-5, view more
    67510-0300-6
  • Packager: Kareway Product, Inc.
  • 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 17, 2023

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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 and gently pulling until backing separates in middle
    • 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, carboxymethylcellulose, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, povidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

  • package label

    Cold and Hot Pain Relief Patch

    carton

  • INGREDIENTS AND APPEARANCE
    COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0300-21 in 1 CARTON02/21/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67510-0300-41 in 1 CARTON02/21/2017
    24 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:67510-0300-31 in 1 CARTON02/21/2017
    33 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:67510-0300-51 in 1 CARTON02/21/2017
    45 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:67510-0300-61 in 1 CARTON02/21/2017
    56 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/21/2017
    Labeler - Kareway Product, Inc. (121840057)
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