Label: BLUE DEVIL HAND SANITIZER- alcohol solution

  • NDC Code(s): 22431-222-01
  • Packager: Blue Cross Laboratories
  • 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 15, 2020

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

  • Active Ingredient(s)

    Ethyl Alcohol 62% Purpose: Antiseptic

  • Purpose

    Uses

    • to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only-hands. Flammable. Keep away from heat or flame

  • Do not use

    • not recommended for infants
  • INDICATIONS & USAGE

    • avoid contact with broken skin
    • do not inhale or ingest
  • WHEN USING

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.


    Stop use and ask a doctor if

    • skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    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.
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    water, glycerin, propylene glycol, carbomer

  • Package Label - Principal Display Panel

    Blue Devil

    Hand Sanitizer

    Fights 99.99% of germs and bacteria

    Helps stop the spread of illness

    Great for travel, home, & workplace

    8oz. 237ml part #00245

    419245

  • INGREDIENTS AND APPEARANCE
    BLUE DEVIL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-222-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - Blue Cross Laboratories (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Daily Chemical Products Co., Ltd530766098manufacture(22431-222)