Label: RELAXIUM- menthol spray

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

Drug Label Information

Updated September 4, 2024

If you are a consumer or patient please visit this version.

  • Menthol ........ 10.5%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product • avoid any contact with the eyes or mucous
    membranes • flush with cold water if accidentally sprayed in eyes • do not apply
    to wounds or damaged skin • do not apply to irritated skin • do not bandage •
    wash hands after use with cool water • do not use with heating pad or device •
    contents under pressure • do not puncture or incinerate • do not use if you are
    allergic to any ingredient in Flexium • do not store at temperature above 120° F

  • STOP USE

    Stop use and ask doctor if • condition worsens, or if symptoms persist for
    more than 7 days, or clear up and reoccur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily

  • INACTIVE INGREDIENT

    Inactive ingredients Alcohol Denat., Arnica Montana Flower Extract, Calendula
    Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract,
    CurcuTame™ Blend [Tamarind (Tamarindus Indica) Extract (Seed), Turmeric (Curcuma Longa)
    Extract (Rhizome), Glucosamine Sulfate, Boron Citrate, Hyaluronic Acid, Chondroitin Sulfate,
    Boswellia Serrata Extract (Gum Resin), Marine Type II Collagen (from Salmon)],
    Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf
    Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

  • QUESTIONS

    Question? 888-353-1205

  • PRINCIPAL DISPLAY PANEL

    Flexium Full Body Pain Relief

  • INGREDIENTS AND APPEARANCE
    RELAXIUM 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMOMILE (UNII: FGL3685T2X)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ELOSULFASE ALFA (UNII: ODJ69JZG85)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-080-0190 g in 1 CAN; Type 0: Not a Combination Product09/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/04/2024
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-080)