AVEDA ACTIVE COMPOSITION - menthol, methyl salicylate liquid 
Aveda Corporation

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.

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AVEDA ACTIVE COMPOSITION

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

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

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

Keep out of reach of children to avoid accidental poisoning.

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

For external use only. Avoid contact with eyes.

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

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.

Topical Analgesic, Aromatic oil relieves tired, sore muscles.

Caprylic/capric triglyceride

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


800-328-0849 USA / 763-783-6999.  www.Aveda.com


Active Composition Bottle

Active Composition Carton

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

Revised: 3/2011
Document Id: 08b34822-5067-4a70-90ee-337b990e5977
Set id: 44bc09f5-b042-4de6-8ede-505b13deef8b
Version: 1
Effective Time: 20110308
 
Aveda Corporation