Label: MCM TOPICAL GEL PATCH- l-menthol patch

  • NDC Code(s): 81877-601-15
  • Packager: FORREAL PHARMACEUTICALS LLC
  • 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 January 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    L-Menthol 76.8mg

    Methyl Salicylate 57.6mg

    DL-Camphor 96.0mg

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

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

    • Arthritis
    • Simple backache
    • Strains
    • Bruises
    • Sprains
  • WARNINGS

    Warnings

    For external use only


    Do not use

    • On wounds or damaged skin
    • If you are allergic to aspirin or salicylates
    • With a heating pad
    • With, or at the same time as other external analgesic products

    Ask a doctor before use if you are allergic to any ingredients in this product.

    When using this product

    • Do not use other than directed
    • Avoid contact with eyes, mucous membranes, and rashes

    Stop use and ask a doctor if

    • Rash, itching, or excessive skin irritation develops
    • Condition worsens
    • Symptoms persist for longer than 7 days
    • Symptoms clear up and reoccur within a few days

    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.

    Caution: This product contains natural rubber latex which may cause allergic reactions.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area no more than 3 to 4 times daily for 7 days
    • Remove patch from skin after at most 8 hours of application
    • Children under 12 years of age: Consult a doctor
  • OTHER SAFETY INFORMATION

    Other Information

    • Avoid storing product in direct sunlight
    • Protect from excessive moisture
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution, Concentrated Glycerin, Dihydroxyaluminum Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified water

  • PRINCIPAL DISPLAY PANEL

    NDC: 81877-601-15

    MCM
    Topical Gel Patch

    (L-Menthol 76.8 mg - Methyl Salicylate 57.6 mg - DL-Camphor 96.0 mg)

    Instant Pain Relief

    JOINT AND MUSCLE PAIN - SPRAINS - BACKACHE

    Forreal Pharmaceuticals LLC
    YOUR SOLUTION TO BETTER HEALTHCARE

    (5 patches per pouch-3 pouches) 15 Patches

    MCM Topical Gel Patch

  • INGREDIENTS AND APPEARANCE
    MCM TOPICAL GEL PATCH 
    l-menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96.0 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GELATIN (UNII: 2G86QN327L)  
    NICOTINATE ETHANOLAMINE (UNII: 71P617JXF6)  
    TARTARIC ACID (UNII: W4888I119H)  
    NONIVAMIDE (UNII: S846B891OR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-601-153 in 1 POUCH01/23/2023
    15 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/23/2023
    Labeler - FORREAL PHARMACEUTICALS LLC (118029197)
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