Label: SUNMED TOPICAL WITH MENTHOL- 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 March 30, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 10.5%

  • PURPOSE

    Menthol 10.4% ................. Topical Analgesic

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only

  • WHEN USING

    When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

  • STOP USE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Extract

    Arctium Lappa Root (Burdock) Extract

    Arnica Montana Flower Extract

    Boswellia Carterii Resin Extract

    Calendula Officinalis Extract

    Camellia Sinensis Leaf Extract

    Camphor

    Carbomer

    FD&C Blue #1

    FD&C Yellow #5

    Full Spectrum Industrial Hemp Extract

    Glycerin

    Ilex Paraguariensis (Mate) Leaf Extract

    Isopropyl Alcohol

    Isopropyl Myristate

    Melissa Officinalis (Lemon Balm) Leaf Extract

    Silica

    Tocopheryl Acetate

    Triethanolamine

    Water

  • PRINCIPAL DISPLAY PANEL

    SUNMED Topical Spray with MENTHOL

  • INGREDIENTS AND APPEARANCE
    SUNMED TOPICAL WITH MENTHOL 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73240-903
    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
    ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
    HEMP (UNII: TD1MUT01Q7)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73240-903-0189 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2022
    Labeler - Sunflora Inc. (067153368)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(73240-903)
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