Label: MEDISTIK COOLING ROLL-ON- menthol, camphor solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 26, 2020

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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

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    When using this product

    • use only as directed
    • avoid getting into the eyes and mucous membranes
    • do not bandage tightly or use with a heating pad
    • do not apply to wounds or damaged skin

    Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation or redness occurs

    If pregnant or breast-feeding, ask a health professional before use.

  • DIRECTIONS

    • For use on adults and children over 12 years of age and older: Apply product on affected area, not more than 4 times daily
    • children under 12 years of age: ask a doctor
  • INACTIVE INGREDIENTS

    Denatured alcohol, Water, Peppermint oil, Glycerin, Polyacrylate Crosspolymer-6, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_MediStik Roll-on

  • INGREDIENTS AND APPEARANCE
    MEDISTIK COOLING ROLL-ON 
    menthol, camphor solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77108-103
    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:77108-103-1189 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/14/2020
    Labeler - Medistik Inc (204132562)
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