Label: OROGIN ESSENTIAL EUCALYPTIC FRESH- alcohol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

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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

    • in children less than 2 months of age
    • on open skin wounds
  • 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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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