Label: MENTHOL spray

  • 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 September 8, 2023

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  • DOSAGE & ADMINISTRATION

    Mist on a handkerchief or pillow, apply directly on chest or back, or spray in the air.

  • WARNINGS

    For external use only.

    Avoid contact with eyes.

    Keep away from flame. Flammable.

  • INACTIVE INGREDIENT

    Alcohol Denat., Aqua, Eucalyptus Globulus Leaf Oil, Isopropyl Alcohol, Propylene Glycol, Parfum, Polysorbate 20, Geraniol, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

  • INDICATIONS & USAGE

    Breathe Easy Spray is enriched with a blend of refreshing essential oils to clear the senses, restore free breathing, and purify the air. The soothing blend of eucalyptus essential oil and menthol helps ease nasal congestion symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children’s reach.

  • PURPOSE

    Analgesic

  • ACTIVE INGREDIENT

    Menthol …………………………………………...………………….……... 2%

  • PRINCIPAL DISPLAY PANEL

    4oz

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80770-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    COUMARIN (UNII: A4VZ22K1WT)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80770-002-04113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/19/202003/27/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/19/202003/27/2025
    Labeler - NATURAL 17 (103497833)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80770-002)
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