Label: LUVONE HAND SANITIZER WITH GLYCERIN- alcohol spray

  • NDC Code(s): 80683-001-01
  • Packager: INDUSTRIAS MC CLEAN S A S
  • 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 December 22, 2020

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

  • Drug Facts:

  • Active Ingredients

    Ethyl Alcohol 70 %

    Purpose:

    Antimicrobial

  • Use:

    Helps to reduce bacterias that potentially can cause disease.

  • Warnings:

    • For External Use Only
    • Flammable. Keep away from the fire or flame

    Keep out of reach of Children,

    • pets and ignition sources.

    Do not use

    in Children less than 2 months, except under adult supervision

    • Do not use on open skin wounds
    • Avoid spraying in eyes, In case of contact, rinse eyes throughly with water
    • If swallowed, get medical help, or contact a Poison Control Center right away
    • Use only as directed. Intentional misues by deliberately concentrating and inhaling the contents can be harmful or fatal
    • Do not use over flames, do not pierce, can be fatal

  • Directions

    Use directly on hands and spread gently

  • Other Information

    Store at room temperature, in a cool and dry place.

    May discolor or damage some fabrics/materials or surfaces.

  • Inactive Ingredients

    Water, Glycerine.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    LUVONE HAND SANITIZER WITH GLYCERIN 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80683-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80683-001-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2021
    Labeler - INDUSTRIAS MC CLEAN S A S (886518381)