Aveda Active Composition
FDA Label NDC 57677-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aveda Corporation for the product Aveda Active Composition (NDC 57677-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, general precautions, otc - stop use, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

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

Otc - 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning.

Otc - 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.

Otc - 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.

Otc - 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.

Otc - Questions

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

Package Label.Principal Display Panel

Active Composition Carton (Acboxa1)

Active Composition Carton (Acboxa1)

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