Label: MEDICATED HEAT- capsicum patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 17, 2010

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  • 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

  • PRINCIPAL DISPLAY PANEL

    Image of carton label

    Image of pouch label


  • INGREDIENTS AND APPEARANCE
    MEDICATED HEAT 
    capsicum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-269
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.6 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-269-6425 in 1 CARTON
    13 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/20/2010
    Labeler - United Exchange Corporation (840130579)
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