Label: AVEDA ACTIVE COMPOSITION- menthol, methyl salicylate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 8, 2011

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

  • ACTIVE INGREDIENT

    Methyl Salicylate 24.9% - Menthol 2.5% (Topical Analgesics)

  • PURPOSE

    Indications:  For the temporary relief of minor aches and pains of muscles and joints.

  • WARNINGS

    Warnings:For external use only. Do not use otherwise than as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning.

  • ASK DOCTOR

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

  • GENERAL PRECAUTIONS

    For external use only. Avoid contact with eyes.

  • STOP USE

    If condition worsens, or if symptoms persist for more that 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

  • DO NOT USE

    Do not apply to wounds or damaged skin. Do not bandage tightly.

  • DOSAGE & ADMINISTRATION

    Directions:  Adults and children 2 years of age and older, apply to affected area not more that 3 to 4 times daily.  Children under 2 years of age: consult a doctor.

  • INDICATIONS & USAGE

    Topical Analgesic, Aromatic oil relieves tired, sore muscles.

  • INACTIVE INGREDIENT

    Caprylic/capric triglyceride

  • HOW SUPPLIED

    Aveda Corp. Dist. Minneapolis, MN 55449-7106. London W1K 3B0. Made in Canada.

  • QUESTIONS


    800-328-0849 USA / 763-783-6999.  www.Aveda.com
  • PRINCIPAL DISPLAY PANEL


    Active Composition Bottle

  • PRINCIPAL DISPLAY PANEL

    Active Composition Carton

  • INGREDIENTS AND APPEARANCE
    AVEDA ACTIVE COMPOSITION 
    menthol, methyl salicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57677-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1.25 mL  in 50 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate12.45 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 28.5 mL  in 50 mL
    JOJOBA OIL (UNII: 724GKU717M) 2.5 mL  in 50 mL
    CAJUPUT OIL (UNII: J3TO6BUQ37) 0.75 mL  in 50 mL
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.75 mL  in 50 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.75 mL  in 50 mL
    CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D) 0.75 mL  in 50 mL
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.625 mL  in 50 mL
    CAMPHOR OIL (UNII: 75IZZ8Y727) 0.5 mL  in 50 mL
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) 0.375 mL  in 50 mL
    SWEET MARJORAM OIL (UNII: ICH7BE016E) 0.375 mL  in 50 mL
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.375 mL  in 50 mL
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.05 mL  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57677-005-021 in 1 BOX
    1NDC:57677-005-0150 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/08/2011
    Labeler - Aveda Corporation (071352058)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Knowlton Inc.248704645manufacture, analysis