Label: ALEVEX- camphor and menthol spray

  • 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 February 10, 2021

If you are a consumer or patient please visit this version.

  • 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
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.5 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)  
    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)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    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)  
    PROPANE (UNII: T75W9911L6)  
    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 not finalpart34804/01/2021
    Labeler - Bayer HealthCare LLC (112117283)