Label: MEDIPAP COOL- l-menthol patch

  • NDC Code(s): 58354-107-01, 58354-107-02
  • Packager: Cho-A Pharm.Co.,Ltd.
  • 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 December 31, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients

    L-Menthol (20mg/11.7g)

  • Purpose

    External analgesic

  • Uses

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

    • Arthritis
    • Simple backache
    • Strains
    • Bruises
    • Sprains
  • 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’ application

    Children undress 12 years of age: consult a doctor

  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • if you are allergic to any ingredients of this product
    • with a heating pad
    • with, or at the same time as, other external analgesic products

    When using this product

    • do not use otherwise than directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly

    Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    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 (1-800-222-1222) right away.

  • Inactive ingredients

    Felbinac, Methylparaben, Propylparaben, Diisopropanolamine, Dipropylene Glycol, Propylene Glycol Monolaurate, Conc. Glycerin, Titanium Oxide, Kaolin, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Sodium Polyacrylate, Gelatin, Carbomer Solution, Tartaric Acid, Ferric Oxide, Butylhydroxytoluene, Purified Water

  • Medipap Cool

    medical cool

  • INGREDIENTS AND APPEARANCE
    MEDIPAP COOL 
    l-menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL20 mg  in 11.7 g
    Inactive Ingredients
    Ingredient NameStrength
    FELBINAC (UNII: 94WNJ5U8L7)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-107-025 in 1 POUCH02/21/2018
    1NDC:58354-107-0111.7 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/21/2018
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd. 688056831manufacture(58354-107)