Label: QC COLD AND HOT PAIN RELIEF- menthol patch 

  • Label RSS
  • NDC Code(s): 63868-012-05
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • 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 11/12

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

  • Active Ingredient

    Menthol 5.0%
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  • Purpose

    Topical Analgesic

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  • Uses

    temporarily relieves minor pain associated with

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

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  • 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

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  • 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

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  • package label

    QC Cold and Hot Patchimage of carton label

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  • INGREDIENTS AND APPEARANCE
    QC COLD AND HOT PAIN RELIEF 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63868-012
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACRYLIC ACID  
    ALUMINUM HYDROXIDE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    METHYL ACRYLATE  
    NONOXYNOL-30  
    POLYSORBATE 80  
    SORBITAN SESQUIOLEATE  
    TALC  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-012-05 1 in 1 CARTON
    1 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/12/2011
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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