Label: ALEVEX- camphor and menthol spray

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    (To Deliver)

    Camphor 5.5%

    Menthol 16%

  • Purpose

    Pain Relieving Spray

  • INDICATIONS & USAGE

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

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises

    Provides penetrating pain relief

  • Warnings

    For external use only

    Flammable: do not use near heat, flame, or while smoking.

    Do not use

    • if you have ever had an allergic reaction to this product or any of its ingredients

    When using this product

    • avoid contact with the eyes and mucous membranes
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal
    • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF
    • do not bandage tightly
    • do not use with a heating pad, medicated patch or other types of local heat
    • do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor if

    • condition worsens or irritation develops
    • pain, swelling or blistering develops where product was applied
    • redness or severe burning develops where product was applied
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    Adults and children 12 years of age and older
    • Shake well before use
    • Apply to affected area not more than 3 to 4 times daily
    • Do not apply to face
    • Use in a well-ventilated area and avoid inhalation
    • Wash hands with soap and water after use if product comes in contact with hands
    Children under 12 years of age
    • Ask a doctor

  • Other information

    • store between 20º-25ºC (68º-77ºF)
  • Inactive ingredients

    boswellia carterii oil, clove oil, dimethylaminoethyl methacrylate copolymer, dimethyl isosorbide, eucalyptus oil, fragrance, isobutane, isopentane, isopulegol, linseed oil, menthoxypropanediol, pepermint oil, propane, propanediol, rosemary oil, SD alcohol 40-B (13% v/v), thymus mastichina flower oil, tocopherol, vanillyl butyl ether, vinyl caprolactam, vinylpyrrolidone

  • Questions

    1-800-395-0689

  • Package label display

    ALEVEX™

    PAIN RELIEVING

    SPRAY

    MAX

    STRENGTH

    MENTHOL

    COOLS IN

    SECONDS

    FOR EXTERNAL

    USE ONLY

    NET WT 3.2 OZ (91 g)

    AleveX Dry Spray label

  • INGREDIENTS AND APPEARANCE
    ALEVEX 
    camphor and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.5 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ISOBUTANE (UNII: BXR49TP611)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    PROPANE (UNII: T75W9911L6)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    ISOPENTANE (UNII: ZH67814I0O)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    N-VINYLCAPROLACTAM (UNII: KFC10CY9UP)  
    THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
    ISOPULEGOL (UNII: 3TH92O3BXN)  
    N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
    CLOVE OIL (UNII: 578389D6D0)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0049-0191 g in 1 CAN; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2021
    Labeler - Bayer HealthCare LLC (112117283)
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