Label: ANALGESIC- menthol spray

  • NDC Code(s): 61010-8201-0
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 4, 2024

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  • Active Ingredients

    USP Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief of minor aches and pains of muscles and joints.

  • Warnings

    For external use only.

    Flammable.

    Keep away from flame.

    Keep out of reach of children.

    If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes.

    Do not apply to open wounds or damaged skin. Do not bandage tightly.

    Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates,including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

  • Directions

    For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

  • Principal Display Panel - Pain Relief Spray Bottle Label

    NDC 61010-XXXX-X

    Safetec

    PAIN
    RELIEF
    SPRAY

    MEDICATED FAST-ACTING

    For temporary relief of minor aches and pains

    2 fl. oz. (59.1 ml)

    Principal Display Panel - Pain Relief Spray Bottle Label
  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL70 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-8201-00.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/01/2018
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262manufacture(61010-8201)
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