Label: 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 4, 2014

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  • Active Ingredient

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
  • 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

    Avoid the eyes and mucous membranes.
    In case of contact; rinse area thoroughly with water

  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center immediately.

  • Directions

    Rub dime sized amount between hands until dry

  • Other Information

    Store below 105F
    May discolor some fabrics

  • Inactive ingredients 

    Benzophenone-4, Carbomer, Fragrance, FDC Blue 1, DC Red 33, Glycerin, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Tocopherol and Jojoba Oil, Triethanolamine, Water (Aqua)

  • Package Label

    image of package label

  • INGREDIENTS AND APPEARANCE
    ANTI BACTERIAL HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-160
    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
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-160-3030 mL in 1 BOTTLE, PLASTIC
    2NDC:49852-160-4040 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/15/2011
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture(49852-160)
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