Label: HOT PAIN RELIEF- capsaicin patch 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 June 26, 2017

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

  • PURPOSE

    Uses

    For temporary relief associated with:

    • Arthritis
    • Backaches
    • Bruises
    • Sprains & Strains
    • Joint & Muscle Pain

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use:

    • On the face or rashes
    • With a heating pad
    • On wounds or damaged skin
    • if you are allergic to any ingredients of this product
  • WHEN USING

    When using this product:

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashes
  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    Adults and Children 12 years of age and over:

    Clean and dry affected area.
    Peel off protective film and apply patch once or twice a day.
    Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.

    Children Under 12 Years of Age: Consult a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyster resin, zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    MCURE HEALTH SOLUTIONS INC.

    20819 Currier Rd #200

    City of Industry, CA 91789

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    PA-200

  • INGREDIENTS AND APPEARANCE
    HOT PAIN RELIEF 
    capsaicin patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.2 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    BELLADONNA LEAF (UNII: 6GZW20TIOI)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLE (13cm*18cm) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-002-254800 mg in 1 PATCH; Type 0: Not a Combination Product06/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/27/2017
    Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)
    Registrant - MCURE HEALTH SOLUTIONS INC. (053034873)
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