Label: ORBEL- ethyl alcohol liquid

  • 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 May 8, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Ethyl Alcohol-72%

  • Purpose

    Antiseptic Hand Rub

  • Uses

    Hand sanitizer to decrease bacteria on the skin that potentially can cause disease. Recommended for repeated use.

  • Warnings

    For external use only

    Avoid contact with eyes.

    In case of eye contact, rinse eyes thoroughly with water. Discontinue use if irritation and redness  develop.

    Consult a doctor if condition persists for more than 72 hours.

    Keep out of reach of children unless under adult supervision.

    If swallowed, immediately call Poison Control Center or doctor.

  • Directions

    • Apply small amount into your palm and thoroughly spread on both hands. Rub into skin until dry.
  • Questions or Comments ? :

    Call +44 (0) 7970 443778

    Hours M-F 9am-4pm (GMT)

  • Other Information

    • Store at 20-25°C
  • Inactive ingredients

    DI water, Glycerin, Methylglucamine, Hydroxyethylcellulose, Fragrance

  • Principal Display Panel

    Orbel

    Ethyl Alcohol 72%

    Orbel front

    Orbel back

  • INGREDIENTS AND APPEARANCE
    ORBEL 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61805-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEGLUMINE (UNII: 6HG8UB2MUY)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    COUMARIN (UNII: A4VZ22K1WT)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EVERNIA PRUNASTRI (UNII: O3034Q5AHK)  
    PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61805-090-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/08/2019
    Labeler - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)
    Registrant - Bath Concept Cosmetics (Dongguan) Co., Ltd (529623933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(61805-090)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!