Label: TEA TREE ANTISEPTIC- melaleuca alternifolia ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 51257-644-01 - Packager: Integria Healthcare US Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 17, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TEA TREE ANTISEPTIC
melaleuca alternifolia ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51257-644 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 2.5 g in 50 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) CANOLA OIL (UNII: 331KBJ17RK) CARNAUBA WAX (UNII: R12CBM0EIZ) MACADAMIA OIL (UNII: 515610SU8C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51257-644-01 50 g in 1 JAR 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