Label: K19 RELIEF- menthol liquid

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

Drug Label Information

Updated November 6, 2023

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  • DRUG FACTS:

  • Active Ingredient:

    Menthol 1.25%

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes and mucous membranes.
    • If symptoms persist for more than 7 days, discontinue use and consult physician.

    Keep Out of reach of children.

    • If swallowed, consult physician.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.
    • Chidlren under 2 years of age: consult a physician.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    K19 RELIEF 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83574-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83574-413-00295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/10/2023
    Labeler - K19 LLC (090893478)
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