QC COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [QUALITY HOME PRODUCTS]

QC COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [QUALITY HOME PRODUCTS]
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NDC 64525-5131-5
Set ID 2df08319-cf75-493f-87bf-a525c8585528
Category HUMAN OTC DRUG LABEL
Packager Quality Home Products
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Menthol 5.0%
  • Purpose

    Topical Analgesic Patch
  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with
    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 10 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • Children under 10 years of age: do not use, consult a doctor
  • Inactive ingredients

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

  • package label


    QC Cold and Hot Patch
    image of carton label
  • INGREDIENTS AND APPEARANCE
    QC COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64525-5131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64525-5131-51 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 - Quality Home Products (205554157)

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