Label: FLEXSPORT ROLL ON- methyl salicylate liquid

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

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active ingredient and Purpose

    Active ingredientPurpose
    Menthol 16% ....................Topical analgesic

  • Uses

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

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • Warnings

    For external use only. Avoid contact with the eyes.

    Flammable: keep away from fire or flame.

    When using this product

    • do not bandage tightly or use with a heating pad
    • do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • 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 right away.

  • Directions

    • use only as directed
    • adults and children over 12 years: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • Other information

    • store at temperatures not exceeding 15°–30°C (59°– 86°F)
    • avoid excessive heat and humidity
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

  • Questions or Comments?

    1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com

  • Principal Display Panel

    Topical Analgesic Liquid

    FlexSport

    Pain Relief

    ROLL-ON

    • Muscle & Joint Pain
    • Backaches
    • Arthritis

    3 fl oz (89 mL)

    FS PDP

  • INGREDIENTS AND APPEARANCE
    FLEXSPORT ROLL ON 
    methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-360
    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
    CAPSAICIN (UNII: S07O44R1ZM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-360-031 in 1 BOX04/04/2021
    189 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/04/2021
    Labeler - Pharmadel LLC (030129680)
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