Label: PARCHE LEON MILAGROSO DUAL ACTION- capsaicin, menthol 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 July 1, 2016

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  • Drug Facts

  • Active Ingredients

    Capsaicin 0.0375%

    Menthol 5%

    Purpose

    Topical Analgesic

  • Uses

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

    • simple backaches
    • arthritis
    • strains
    • sprains
  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

    Allergy Alert: This product contains natural rubber latex which may cause allergy reactions.

    Do not use

    • on wounds or damaged skin
    • with a bandage or heating pad
    • on sensitive skin
    • if allergic to any ingredients in this product

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

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

  • Directions

    • adults & children 12 yrs of age & older: apply to affected area not more than 3 to 4 times daily
    • children under 2 year of age: consult a doctor
    • clean and dry affected area
    • remove patch from film
    • apply sticky side of patch to affected area
    • use one patch at a time
    • leave patch on affected area for up to 8-hours at a time
  • Inactive ingredients:

    aloe barbadensis leaf (aloe vera gel) juice, diazolidinyl urea, EDTA disodium, glycerin, iodopropynyl butylcarbamate, methylparaben, polysorbate 80, propylparaben, sodium polyacrylate, water.

  • Other information:

    • store at room temperature 59-86°F (15-30°C)
    • do not store in direct sunlight or expose to excessive heat

    TAMPER EVIDENT:

    Do not use if packet containing the patch is torn or broken.

  • Questions & comments?

    1-899-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadelusa.com

  • PRINCIPAL DISPLAY PANEL

    Topical Analgesic Patches

    Dual Action Pain Relief

    For the temporary relief of:

    • Sore Muscules
    • Backache
    • Arthritis
    • Joint Pain

    PDP Panel

  • INGREDIENTS AND APPEARANCE
    PARCHE LEON MILAGROSO  DUAL ACTION
    capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-046-066 in 1 CARTON02/01/2016
    12.27 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2016
    Labeler - Pharmadel LLC (026095439)
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