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
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 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)
