OTC Medication Information: Aveda Active Composition

AVEDA ACTIVE COMPOSITION — menthol and 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.

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

AVEDA ACTIVE COMPOSITION menthol, methyl salicylate liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57677-005 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (Menthol) Menthol 1.25 mL in 50 mL METHYL SALICYLATE (Methyl Salicylate) Methyl Salicylate 12.45 mL in 50 mL

Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES 28.5 mL in 50 mL JOJOBA OIL 2.5 mL in 50 mL CAJUPUT OIL 0.75 mL in 50 mL EUCALYPTUS OIL 0.75 mL in 50 mL LAVENDER OIL 0.75 mL in 50 mL CITRUS AURANTIUM LEAFY TWIG OIL 0.75 mL in 50 mL PEPPERMINT OIL 0.625 mL in 50 mL CAMPHOR OIL 0.5 mL in 50 mL GERANIUM OIL, ALGERIAN TYPE 0.375 mL in 50 mL SWEET MARJORAM OIL 0.375 mL in 50 mL ROSEMARY OIL 0.375 mL in 50 mL ALPHA-TOCOPHEROL 0.05 mL in 50 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57677-005-02 1 BOTTLE, GLASS (CARTON) in 1 BOX contains a BOTTLE, GLASS (57677-005-01) 1 NDC:57677-005-01 50 mL in 1 BOTTLE, GLASS This package is contained within the BOX (57677-005-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 03/08/2011

Labeler — Aveda Corporation (071352058)

Establishment
Name	Address	ID/FEI	Operations
Les Emballages Knowlton Inc.		248704645	manufacture, analysis

Revised: 03/2011 Aveda Corporation