Label: MEGA PATCH- capsaicin, lidocaine, menthol, methyl salicylate patch

  • NDC Code(s): 82219-411-10
  • Packager: GREENHILL TRADING, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 21, 2023

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  • Drug Facts Active Ingredients

    Capsaicin 0.0375%

    Lidocaine 4%

    Menthol 5%

    Methyl Salicylate 20%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.

  • Warnings:

    For external use only.

    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not use with heating devices or pads.
    • Do not use on wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
    • Do not cover with bandages.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chlidren.

    If swallowed, call poison control.

    If contact does occur with eyes, rinse with cold water and call a doctor.

  • WARNINGS AND PRECAUTIONS

    Children under 12 years old, consult a doctor before use.

    • If you are allergic to any ingredients in this product consult a doctor before use.
    • Consult your physician: If pregnant or if pain persists or worsens.
  • DOSAGE & ADMINISTRATION

    Directions: Apply patch to affected area 1 to 2 times daily or as directed by physician. Clean and dry the affected area. Open pouch and remove protective film and apply patch to affected area. Wash hands with soap and water after applying patch. Reseal pouch containing unused patches after use.

  • OTHER SAFETY INFORMATION

    Other information: Store below 90°F/32°C

  • INACTIVE INGREDIENT

    Inactive Ingredients: Glycerin 25%, Polyacrylic Acid 5%, Propylene Glycol 2%, Methyl salicylate, Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Isopropyl Myristate, Tartaric Acid, Propylene Glycol, Sorbitol, EDTA2-NA, Propyl P-Hydroxybenzoate, Tween 80, Titanium Dioxide, Extra Medical Purified Water.

  • QUESTIONS

    Questions? 718-227-5048

    Manufactured For: Greenhill Trading Inc.

    Brooklyn, NY 11234
    718-227-5048

  • PRINCIPAL DISPLAY PANEL

    NDC: 82219-411-10

    GREENHILL
    TRADING
    INC

    Mega Patch

    With Capsaicin 0.0375%, Lidocaine 4%,
    Menthol 5%, Methyl Salicylate 20%

    10 PATCHES
    Patch size 10x14 CM

    EXTENDED
    RELEASE

    Figure

  • INGREDIENTS AND APPEARANCE
    MEGA PATCH 
    capsaicin, lidocaine, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82219-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TARTARIC ACID (UNII: W4888I119H)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82219-411-1010 in 1 POUCH08/21/2023
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/21/2023
    Labeler - GREENHILL TRADING, INC. (965879054)
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