Label: IRIS ANTIMICROBIAL HAND SANITIZER- alcohol soap

  • 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 October 15, 2013

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

View All Sections
  • Active ingredient

    Ethyl Alcohol 62 % w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

     to sanitize hands without requiring water or a rinse

  • WarningsFor external use only

    When using this product

     do not use near heat or flame

     do not use in or near eyes

     discontinue use if irritation and redness develop

  • Directions

     apply to hands and rub in   allow to dry without wiping or rinsing

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Aloe Barbadensies Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label Moisturizing IRIS  Antimicrobial Hand Sanitizer CAUTION: Keep out of reach of childrenSee back panel for additional precautions. 16 Fl oz (1 pint) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    IRIS ANTIMICROBIAL HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59860-519
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59860-519-84473 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2013
    Labeler - Smart and Final Stores (556948354)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!