Label: PARCHE LEON- capsaicin, camphor, menthol patch

  • NDC Code(s): 55758-039-01, 55758-039-06
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active ingredients & Purpose

    Active ingredients (in each patch) Purpose

    Camphor 3%.............................................................

    		External analgesic

    Menthol 1.25%..........................................................

    		External analgesic

    Capsaicin 0.025%.....................................

    		External analgesic
  • Uses

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

    • simple back aches
    • arthritis
    • strains
    • sprains

  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

    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
    • 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 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years 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
  • 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.

  • Inactive Ingredients

    None

  • Questions or Comments?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • Principal Display Panel

    NDC 55758-039-06

    PARCHE LEON

    External Analgesic

    Penetrating pain relief of:

    • Back Aches
    • Muscles
    • Arthritis

    6 Adhesive Plaster Patches

    4.72 in x 7.07 in (12 cm x 18 cm)

    Pain Relieving

    HOT PATCH

    POUCHBOX

  • INGREDIENTS AND APPEARANCE
    PARCHE LEON 
    capsaicin, camphor, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1.25 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-039-011 in 1 POUCH; Type 0: Not a Combination Product02/28/2020
    2NDC:55758-039-066 in 1 CARTON02/28/2020
    2NDC:55758-039-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/28/2020
    Labeler - Pharmadel LLC (030129680)
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