Label: ACTIVICE- menthol spray

  • NDC Code(s): 53329-996-04
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active ingredient

    Menthol 10.0%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

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

    For external use only. Avoid contact with eyes

    Flammable: keep away from fire or flame

    Do not puncture or incinerate. Contents under pressure.

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • do not apply to wounds or damaged skin

    Stop use and ask doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • excessive irritation of the skin develops

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep our of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children over 12 years:

    • spray directly onto affected area without the need to rub, massage or bandage
    • repeat if necessary, but do not apply more than 4 times daily

    Children 12 years or younger:

    • ask a doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    boswellia serrata extract, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerine, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, water (USP)

  • Manufacturing information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in USA with
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: MDSAICESPRY4
    V3 RF23MFO

    *This product is not manufactured or distributed by Performance Health and/or its subsidiaries, owner of the registered trademark Biofreeze®.

  • Package Label

    Label V3 RF23MFO

  • INGREDIENTS AND APPEARANCE
    ACTIVICE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-996
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-996-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2020
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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