Label: ALEVEX- camphor and menthol lotion

  • 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 28, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 5.5%
    Menthol 16%

  • Purpose

    Pain Relieving Lotion

  • Uses

    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: Keep away from fire or flame.

    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
    • 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

    • 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 healthcare professional before use.

    Keep out of reach of children

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

  • Directions

    Adults and children 12 years of age and older
    • Apply to affected area not more than 3 to 4 times daily
    • 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

    aminomethyl propanol, boswellia carterii oil, carbomer interpolymer, clove oil, edetate disodium, eucalyptus oil, fragrance, glycerin, isopulegol, linseed oil, menthoxypropanediol, pentylene glycol, peppermint oil, polysorbate 80, purified water, rosemary oil, SD alcohol 40-B (20.9 % v/v), sorbitan monooleate, thymus mastichina flower, tocopherol, vanillyl butyl ether

  • Questions or comments?

    1-800-395-0689 (Mon - Fri 9AM - 5PM EST)

  • AleveX Carton label 72 grams

    NEW!
    DIFFERENT INGREDIENTS
    MENTHOL + CAMPHOR
    ALEVEX™
    PAIN RELIEVING
    LOTION
    MAX STRENGTH
    MENTHOL
    MASSAGING
    STAINLESS

    STEEL
    ROLL-ON

    FOR EXTERNAL
    USE ONLY
    NET WT 2.5 OZ. (72 g)

    AleveX label 72 grams

  • INGREDIENTS AND APPEARANCE
    ALEVEX 
    camphor and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0050
    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
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    ISOPULEGOL (UNII: 3TH92O3BXN)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CLOVE OIL (UNII: 578389D6D0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0050-011 in 1 CARTON04/01/2021
    172 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2021
    Labeler - Bayer HealthCare LLC (112117283)