Label: PAIN RELIEF- 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 December 3, 2021

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  • Active ingredient

    Menthol 10%

  • Purpose

    Menthol 10%...................Topical Analgesic

  • Uses

    temporarily relieves the minor aches and pains of muscles and joints associated with:

    • strains
    • bruises
    • simple backache
    • arthritis
    • sprains
  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged, broken, or irritated skin
    • with a heating pad

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding, 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 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • Children under 12 years of age: ask a doctor
  • Inactive ingredients

    SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract

  • PRINCIPAL DISPLAY PANEL

    Sagely Naturals

    Extra Strength

    Pain Relief Spray

    95% Natural Ingredients

    Instant Cooling

    with 10% Menthol

    2 Fl Oz / 60 mL

    1

    2

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-430
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82075-430-301 in 1 CARTON11/19/2021
    160 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/19/2021
    Labeler - Sagely Enterprises Inc. (117049032)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab078717086manufacture(82075-430)
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