Label: ANALGESIC- menthol spray

  • NDC Code(s): 61010-8200-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Pain Spray

    Drug Facts

  • Active Ingredients

    USP Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses:

    For the 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 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.

    Manufactured by
    SAFETEC OF AMERICA, Inc. Buffalo, NY 14215
    800-456-7077 www.safetec.com

  • PRINCIPAL DISPLAY PANEL

    NDC 61010-8200-1

    Safetec

    First Aid

    Pain Spray

    For Temporary

    Pain Relief of

    Minor Aches

    And Pains

    4 fl. oz. (118 ml)

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM70 mg  in 1 mL
    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:61010-8200-1118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/26/2011
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-8200)
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