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Medicated Heat (United Exchange Corporation)

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PATCH 25 POUCH in 1 CARTON (55264-269-64) > 3 PATCH in 1 POUCH Label Information

Complete Medicated Heat Information

  • ACTIVE INGREDIENT

    Active Ingredient

    Capsicum extract 0.025 % as Capsaicin


  • PURPOSE

    Purpose

    Topical Analgesic



    Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises

  • WARNINGS

    Warnings

    • For external use only.
    • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.
    • If pregnant or breastfeeding consult a healthcare professional before use.
    • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.

  • DO NOT USE

    Do not use

    • on wounds or damage skin
    • with, or at the same time as, other external analgesic products

  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days or clear up and occur again within a few days
    • rash, itching or excessive skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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


  • DOSAGE & ADMINISTRATION

    Directions

    adults and children under 12 years of age and older

    • clean and dray affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily for 7 days
    • remove patch from the skin after at most 8 hours application

    children under 12 year of age consult a doctor


  • STORAGE AND HANDLING

    Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture

  • INACTIVE INGREDIENT

    Inactive Ingredients

    BHT, Ester gum, Isopropyl myristate, Natural rubber, Polybutene, Polyisobuthylene, Precipitated calcium carbonate, Propylene carbonate, Quinton, Sorbitan monostearate, Titanium oxide, YS resin, Zinc oxide


  • INGREDIENTS AND APPEARANCE
    MEDICATED HEAT 
    capsicum patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-269
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.6 mg
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55264-269-64 25 in 1 CARTON
    1 3 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/20/2010
    Labeler - United Exchange Corporation (840130579)