Label: WATERLESS ANTI BACTERIAL HAND SANITIZER- ethyl alcohol liquid

  • 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 July 15, 2010

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

View All Sections
  • Active Ingredient

    Ethyl Alcohol 63%

  • Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    • For external use only
    • Flammable, keep away from fire and flame
    • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
  • When using this product

    • avoid the eyes an mucous membranes
    • in the case of eyes or mucous membrane contact; rinse area thoroughly with water
  • Stop use and ask a doctor if

    • condition worsens
    • redness or irritation develops
    • if condition persists for more than 3 days
  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center immediately.

  • Directions

    • Rub quarter sized amount between hands until dry
    • Supervise children in the use of this product

  • Other information

    • Store below 105F
    • May discolor some fabrics
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, DC Red 33, FDC Blue 1, Fragrance, Propylene Glycol, Triethanolamine, Water
  • Package Label

    Package Label
    image of package label


  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI BACTERIAL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-034-03100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33308/01/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture
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!