Label: FLORANCE MORRIS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 76612-180-10, 76612-180-12, 76612-180-25, 76612-180-37, view more
    76612-180-50
  • Packager: Asimex International Llc
  • 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 4, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 80%

  • Purpose

    Antiseptic

  • Use

    ■To decrease bacteria on the skin that could cause disease

    ■Recommended for repeated use

  • Warnings

    For external use only: hands.

    ■Flammable ■Keep away from fire or flame

    When using this product ■Keep out of eyes ■In case of contact with eyes, flush thoroughly with water ■Avoid contact with broken skin ■Do not inhale or ingest

    Stop use and ask a doctor if ■Irritation or redness develops. ■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

    Thoroughly cover your hands with product and allow to dry without wiping ■Children under 6 years of age should be supervised when using this product ■Not recommended for infants

  • Other information

    Store below 105°F ■May discolor some fabrics ■Harmful to wood finishes and plastics

  • Inactive ingredients

    Cellulosic thickener, Glycerin, Triethanolamine, Water

  • QUESTIONS

    Questions? +1-786-843-1308
    You may also report serious side effects to this phone number.
    Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Florance Morris

    body care

    Distributed by: Asimex International LLC

    9100 S Dadeland Blvd,

    Ste 912 Miami, FL, 33156

    COUNTRY OF ORIGIN: MEXICO

    Lot No:

    Expiry:

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    FLORANCE MORRIS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76612-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76612-180-12125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    2NDC:76612-180-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    3NDC:76612-180-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    4NDC:76612-180-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    5NDC:76612-180-374000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/23/2020
    Labeler - Asimex International Llc (025004798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grupo Asimex de México, S.A. de C.V.812962512manufacture(76612-180)
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