Label: MEDISTIK PROFESSIONAL ICE THERAPY- menthol, camphor gel

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

Drug Label Information

Updated January 29, 2024

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  • ACTIVE INGREDIENTS

    Menthol 10%

    Camphor 4%

  • PURPOSE

    Topical Analgesic

  • USES

    For the temporary relief of sore muscles and joints associated with

    • strains and sprains
    • backaches
    • lumbago
    • pain of tendons and/or ligaments
    • arthritic or rheumatic pain
  • WARNINGS

    For external use only. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

    Stop use and consult a physician if condition worsens, rash or irritation develops, or if symptoms persist for more than 7 days or clear up and recur in a few days. Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Rashes and/or burning discomfort, and hypersensitivity such as allergy have been known to occur; in which case, discontinue use.

  • DIRECTIONS

    For use on adults and children over 12 years of age.

    Apply to affected area(s) 3 to 4 times per day as required. A stinging or burning sensation will be experienced during the first few minutes as the formula begins working. For arthritis or muscle pain of the hands, retain for at least 10 minutes then wash hands.

  • INACTIVE INGREDIENTS

    Denatured alcohol, Water, Peppermint oil, Glycerin, Acrylates copolymer, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

  • KEEP OUT OF REACH OF CHILDREN

    Cautions: Keep out of reach of children. If overdose or accidental ingestion occurs, call a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    Medistik Professional Ice Therapy Gel-Label

  • INGREDIENTS AND APPEARANCE
    MEDISTIK PROFESSIONAL ICE THERAPY 
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50231-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
    FOLIC ACID (UNII: 935E97BOY8)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50231-421-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/17/2016
    Labeler - Natureteq Inc. (243737371)