DREUMEX OMNICARE HAND SANITIZER (ALCOHOL) SPRAY [DREUMEX USA, INC.]

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DREUMEX OMNICARE HAND SANITIZER (ALCOHOL) SPRAY [DREUMEX USA, INC.]
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NDC 53305-065-01, 53305-065-02
Set ID ecc8ee22-cf81-4964-80d3-79711875428e
Category HUMAN OTC DRUG LABEL
Packager Dreumex USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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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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