Label: TEA TREE ANTISEPTIC- melaleuca alternifolia oil
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Contains inactivated NDC Code(s)
NDC Code(s): 51257-640-01, 51257-640-02, 51257-640-03, 51257-640-04 - Packager: Integria Healthcare US Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 17, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
TEA TREE ANTISEPTIC
melaleuca alternifolia oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51257-640 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL 15 mL in 15 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51257-640-01 10 mL in 1 BOTTLE 2 NDC:51257-640-02 15 mL in 1 BOTTLE 3 NDC:51257-640-03 25 mL in 1 BOTTLE 4 NDC:51257-640-04 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2011 Labeler - Integria Healthcare US Inc. (962379454) Registrant - Integria Healthcare US Inc. (962379454) Establishment Name Address ID/FEI Business Operations Integria Healthcare (Ballina) 750660367 manufacture