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Capsaicin Pain Relief (Kareway Product, Inc.)

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PATCH 1 POUCH in 1 CARTON (67510-0303-1) > 1 PATCH in 1 POUCH Label Information

Complete Capsaicin Pain Relief Information

  • Active ingredient

    Capsicum extract 0.025% as Capsaicin


  • Purpose

    Topical analgesic


  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

  • 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.

    Do not use
    • on wounds or damaged skin
    • with a heating pad
    • with, or at the same times as other external analgesic products
    • if you are allergic to any ingredients of this product

    When using this product
    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes

    Stop use and ask a doctor if
    • rash, itching or excessive skin irritation develops
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms 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 12 years of age and over:

    • Clean and dry 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 hour's application
    Children under 12 years of age:
    • Consult a doctor


  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture

  • Inactive ingredients

    Butylated Hydroxytoluene, Hydrogenated Rosin Glycerol Ester, Maleated Rosin Glycerin Ester, Natural Rubber, Polybutene, Polyisobutylene, Silicon Dioxide, Titanium Dioxide, Zinc Oxide


  • Package label

    Capsaicin Hot Patchimage of carton label


  • INGREDIENTS AND APPEARANCE
    CAPSAICIN PAIN RELIEF 
    capsaicin patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0303
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.702 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0303-1 1 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 01/23/2012
    Labeler - Kareway Product, Inc. (121840057)