Label: KOFAL FUERTE- methyl salicylate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 28, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredient and Purpose

    Active ingredientPurpose
    Mythyl Salicylate 15%Topical analgesic
  • Use

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

    • backaches
    • arthritis
    • strains
    • bruises
    • sprains

  • Warnings

    For external use only. Avoid contact with the eyes

    Do not

    • apply to wounds or damaged skin
    • bandage tightly

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again 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 immediately.

  • Directions

    • adults and children 2 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
  • Other information

    • store in a cool dry place between (59-86°F)15-30°C
    • don’t use if seal over jar is broken, torn, or missing
  • Inactive ingredients

  • Principal Display Panel

    KOFAL ® Fuerte

    Deportistas - Athletes

    Pain relieving ointment

    Pomada analgesico

    4 oz (113 g)

    PDP Kofal 4 Oz

  • INGREDIENTS AND APPEARANCE
    KOFAL FUERTE 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-107-04113 g in 1 JAR; Type 0: Not a Combination Product12/03/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/03/2015
    Labeler - PHARMADEL LLC (030129680)
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