OROGIN ESSENTIAL EUCALYPTIC FRESH- alcohol solution 
Global Impact Innovation LLC

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.

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Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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 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.

Directions

Other information

Inactive ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Cryalate Crosspolymer, Aminomethylpropanol, Vitamin E Acetate, Eucalyptus Oil

Package Label - Principal Display Panel

OROEUC8ozLabel

236 mL NDC: 74588-591-10

OROEUC16ozLabel

473 mL NDC: 74588-591-11

OROEUC32ozLabel

945 mL NDC: 74588-591-12

OROEUC1GLabel

3.78 L NDC: 74588-591-04

OROGIN ESSENTIAL EUCALYPTIC FRESH 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74588-591
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL170.3436 mL  in 236.588 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74588-591-10236.588 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
2NDC:74588-591-11473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
3NDC:74588-591-12946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
4NDC:74588-591-043785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2020
Labeler - Global Impact Innovation LLC (117465830)

Revised: 6/2020
Document Id: a70ce788-4bf3-3e6d-e053-2995a90a2ee7
Set id: a70d4252-a2ec-3612-e053-2995a90a5b03
Version: 1
Effective Time: 20200601
 
Global Impact Innovation LLC