Label: ACTIVICE- menthol spray

  • NDC Code(s): 53329-991-04
  • 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 December 15, 2022

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  • Active Ingredient

    Menthol 8.0%

  • 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 a 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 out of reach of children.

    If swallowed, get medical helop 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

    citric acid, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, peppermint oil, SD alcohol 39C, water.

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in USA
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: MDSAICESPRY, V2 RJ21MFO

    REF: MDSAICESPRYR, V2 RJ21MFO

  • Package Labels

    Label RH19MFOLabel V3 RJ21MFO

  • INGREDIENTS AND APPEARANCE
    ACTIVICE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-991
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-991-04113.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/04/2019
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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