Label: FLEXSPORT ROLL ON- methyl salicylate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 9, 2021

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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
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    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)  
    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 finalpart34804/04/2021
    Labeler - Pharmadel LLC (030129680)
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