Label: QC 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 November 7, 2012

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  • Active Ingredient

    Menthol 5.0%
  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with

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

    For external use only

    When using this product

    • use only as directed
    • avoid contact with eyes and mucous membranes
    • do not bandage tightly or use with a heating pad
    • do not apply to wounds or damaged skin, broken or irritated skin

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or 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.

  • 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 12 years or younger: ask a doctor

  • Inactive ingredients

    Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Purified Water, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

  • package label

    QC Cold and Hot Patchimage of carton label

  • INGREDIENTS AND APPEARANCE
    QC COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-012-051 in 1 CARTON
    15 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/12/2011
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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