Label: FLEXACURE- menthol spray

  • 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 October 14, 2019

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  • ACTIVE INGREDIENT

    Menthol USP 2.25%

  • DOSAGE & ADMINISTRATION

    Apply as needed.

  • WARNINGS

    (for external use only)

    When using this product

    • use only as directed

    • do not bandage tightly or use with heating pad

    • avoid contact with eyes or mucous membranes

    • do not apply to wounds or damaged skin

    Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops

    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.

  • INSTRUCTIONS FOR USE

    adults and children 12 years of age and older:

    • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but not more than 3 to 4 times daily

    children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Arnica Montana Flower Extract, Chondroitin Sulfate, Dimethyl Sulfone USP (MSM), Dimethyl Sulfoxide USP (DMSO), Glucosamine HCL (Shellfish), Glycerin, Hydrogen Peroxide, Magnesium Chloride, Propylene Glycol, Water (Aqua)

  • OTHER SAFETY INFORMATION

    Persons with a known allergy to shellfish or sulfur should not use this product

  • STATEMENT OF IDENTITY

    Dist. by: Symedic LLC Las Vegas, NV 89147

    MADE IN USA ©2019 FlexaCure

    www.flexacure.com

  • INDICATIONS & USAGE

    Uses: Temporarily relieves minor pain associated with:

    • arthritis • simple backache • muscle strains

    • sprains • bruises • cramps

  • PURPOSE

    Topical Analgesic

  • PRINCIPAL DISPLAY PANEL

    Active Ingredients

  • INGREDIENTS AND APPEARANCE
    FLEXACURE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71402-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    DIMETHYL SULFATE (UNII: JW5CW40Z50)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71402-007-0129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/14/2019
    Labeler - Symedic LLC (060844542)
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