Label: DREUMEX OMNICARE HAND SANITIZER- alcohol spray

  • 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 September 5, 2018

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  • Active Ingredient

    Ethyl Alcohol, 80%

  • Purpose

    Antibacterial

  • Uses

    For hand cleaning to decrease bacteria on the skin.

    Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame. No Smoking.

  • When using this product

    avoid contact with face, eyes and broken skin. If eye contact occurs, rinse eyes thoroughly with water and seek medical advice.

  • Stop use and ask a doctor

    if irritation or redness develops.

  • Contents under pressure.

    Do not puncture or incinerate. Do not store at temperatures above 120°F (50°C).

  • Keep out of reach of children.

    If swallowed get medical help, or contact a poison control center immediately.

  • Directions

    • apply a palmful to hands
    • scrub thoroughly until dry
  • Inactive Ingredients

    water panthenol, glycerin, cetyl alcohol, propylene glycol.

  • For questions or comments

    or to report any adverse reactions or side effects, please call 1-800-233-9382.

  • Principal Display Panel -- Label on individual unit can

    Container Label

  • Carton Label -- package of 6 cans

    Carton Label

  • INGREDIENTS AND APPEARANCE
    DREUMEX OMNICARE HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53305-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mg  in 1.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 400 mg  in 1.2 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53305-065-026 in 1 CASE12/15/2016
    1NDC:53305-065-01400 mL in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/01/2012
    Labeler - Dreumex USA, Inc. (003003118)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dreumex USA, Inc.003003118label(53305-065)
    Establishment
    NameAddressID/FEIBusiness Operations
    BiB Production and Packaging B.V.409606985manufacture(53305-065)
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