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Medicated Pain Relief (American Sales Company)

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PATCH 4 POUCH in 1 CARTON (41520-911-04) > 1 PATCH in 1 POUCH Label Information

Complete Medicated Pain Relief Information

  • Active Ingredient

    Menthol 5%

  • Purpose

    Topical analgesic

  • Use

    • temporarily relieves minor aches and pains of muscles and joints associated with:
      • simple backache
      • arthritis
      • bruises
      • sprains

  • Warnings

    For external use only

    Do not use
    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before using if you have
    • redness over the affected area

    When using this product
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs

    Keep out of reach of children.

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


  • Directions

    • open pouch and remove patch
    • if desired, cut patch to size
    • peel off protective backing and apply sticky side to affected area
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

  • Other information

    • store at 20° to 25°C (68°F to 77°F)



  • Inactive ingredients

    Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose 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

    Pain Relieving Patchimage of carton label


  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-911
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 428.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-911-04 4 in 1 CARTON
    1 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/16/2011
    Labeler - American Sales Company (809183973)