Label: AVEDA ACTIVE COMPOSITION- menthol, methyl salicylate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57677-005-01, 57677-005-02 - Packager: Aveda Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 8, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
- GENERAL PRECAUTIONS
- STOP USE
- DO NOT USE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- HOW SUPPLIED
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVEDA ACTIVE COMPOSITION
menthol, methyl salicylate liquidProduct 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