Label: ELMORE OIL- eucalyptus oil and tea tree oil oil
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Contains inactivated NDC Code(s)
NDC Code(s): 69594-002-01, 69594-002-02, 69594-002-03, 69594-002-04 - Packager: Ultra Mix (Aust) Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated April 5, 2016
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- Actives
- INACTIVE INGREDIENT
- Purpose
- Indication and Usage
- Dosage and Administration
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Product Label
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INGREDIENTS AND APPEARANCE
ELMORE OIL
eucalyptus oil and tea tree oil oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69594-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Eucalyptus Oil (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) Eucalyptus Oil 38.6 mg in 1 mL Tea Tree Oil (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) Tea Tree Oil 42.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) VANILLIN (UNII: CHI530446X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69594-002-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2015 2 NDC:69594-002-02 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2015 3 NDC:69594-002-03 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2015 4 NDC:69594-002-04 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/16/2015 Labeler - Ultra Mix (Aust) Pty Ltd (752254649) Establishment Name Address ID/FEI Business Operations Ultra Mix (Aust) Pty Ltd 752254649 manufacture(69594-002)