Label: BIO BUTE- tea tree oil and eucalyptus oil oil
- NDC Code(s): 51083-100-00, 51083-100-01
- Packager: Medivet Pty Ltd
- This is a repackaged label.
- Source NDC Code(s): 43979-400
- Category: OTC ANIMAL 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 September 7, 2012
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- ACTIVE INGREDIENT
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- Keep Out of Reach of Children
- Inactive Ingredient Section
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INGREDIENTS AND APPEARANCE
BIO BUTE
tea tree oil and eucalyptus oil oilProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51083-100(NDC:43979-400) 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 42.5 mg in 1 mL EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 38.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength Olive Oil (UNII: 6UYK2W1W1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51083-100-00 125 mL in 1 BOTTLE, PLASTIC 2 NDC:51083-100-01 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/15/2012 Labeler - Medivet Pty Ltd (757292763) Establishment Name Address ID/FEI Business Operations Elmore Oil Company Pty Ltd 755881968 manufacture, analysis, api manufacture
