AVEDA ACTIVE COMPOSITION- menthol, methyl salicylate liquid

Aveda Active Composition by

Drug Labeling and Warnings

Aveda Active Composition by is a Otc medication manufactured, distributed, or labeled by Aveda Corporation, Les Emballages Knowlton Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVEDA ACTIVE COMPOSITION 
menthol, methyl salicylate liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1.25 mL  in 50 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y)	Methyl Salicylate	12.45 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57677-005-02	1 in 1 BOX
1	NDC: 57677-005-01	50 mL in 1 BOTTLE, GLASS

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	Business Operations
Les Emballages Knowlton Inc.		248704645	manufacture, analysis