Label: ADVANCED HAND SANITIZER- alcohol gel

  • NDC Code(s): 22431-254-01
  • Packager: Blue Cross Laboratories, Inc
  • 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 June 17, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • PURPOSE

    Use

    • To decrease bacteria on the skin that could cause disease.
    • recommended for repeated use
  • 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if

    • Skin irritation develops
  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat 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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • not recommend for infants
  • STORAGE AND HANDLING

    Other information

    • do not store above 105ºF
    • may discolor some fabrics
    • harmful to wood finishes and plasics
  • INACTIVE INGREDIENT

    Inactive ingredients water, glycerin, propylene glycol,carbomer

  • PRINCIPAL DISPLAY PANEL

    Royalty Premier

    Advanced

    Hand Sanitizer

    Fights Germs and Bacteria

    40 FL OZ (1.18 L)

    Royalty Premier Sanitizer back

    Royalty premier Sanitizer front

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-254-011.18 L in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2020
    Labeler - Blue Cross Laboratories, Inc (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blue Cross Laboratories, Inc008298879manufacture(22431-254)