Label: ACTIVICE- menthol spray

  • NDC Code(s): 53329-996-04
  • Packager: Medline Industries, LP
  • 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 August 21, 2023

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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 not finalpart34801/01/2020
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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