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Name:Aveda Active Composition
Manufacturer:Aveda Corporation
Category:Over-the-counter (OTC) Marketed Drugs


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.

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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 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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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