Label: AMOVEO 80%- 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 February 24, 2017

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  • Drug Facts

  • Active Ingredient

    Alcohol 80%

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only.
    Flammable, keep away from fire or flame.

    Do not use

    in the eyes

    Stop use and ask a doctor if:

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping
  • Other Information

    • avoid temperatures over 110°F
    • may discolor certain fabrics
    • harmful to wood finishes and plastics
  • Inactive Ingredients

    Glycerin, PEG-7 Glyceril Cocoate, Water

  • Questions?

    Call 1 - 877 - 874 - 0606 Weekdays, 9AM – 5PM EST

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMOVEO   80%
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49955-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49955-700-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product02/24/2017
    2NDC:49955-700-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/24/2017
    Labeler - Protair-X Health Solutions Inc. (205614519)
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