Label: OROGIN ESSENTIAL EUCALYPTIC FRESH- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 74588-591-04, 74588-591-10, 74588-591-11, 74588-591-12 - Packager: Global Impact Innovation LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 1, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
OROGIN ESSENTIAL EUCALYPTIC FRESH
alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74588-591 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 170.3436 mL in 236.588 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 3.4305 mL in 236.588 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1183 mL in 236.588 mL WATER (UNII: 059QF0KO0R) 55.2945 mL in 236.588 mL EUCALYPTOL (UNII: RV6J6604TK) 0.349 mL in 236.588 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.3312 mL in 236.588 mL CARBOMER 940 (UNII: 4Q93RCW27E) 6.7213 mL in 236.588 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74588-591-10 236.588 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 2 NDC:74588-591-11 473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 3 NDC:74588-591-12 946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 4 NDC:74588-591-04 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2020 Labeler - Global Impact Innovation LLC (117465830)