Label: WATERLESS ANTI-BACTERIAL HAND CLEANSER- 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 December 30, 2009

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  • ACTIVE INGREDIENT

    Active Ingredient
    Alcohol 65%

  • PURPOSE

    Purpose
    Antiseptic



  • INDICATIONS & USAGE

    Use

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


    Warnings
    • For external use only
    • Flammable, keep away from fire and flame
  • WHEN USING

    When using this product

    • Avoid the eyes and mucous membranes
    • In the case of eyes or mucous membrane contact, rinse area thoroughly with water
  • STOP USE

    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

    Keep out of reach of children If swallowed contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • Spray on hands and rub together until dry
    • Supervise children in the use of this product
    • In the case of eye contact, rinse eyes thoroughly with water
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store below 105 F
    • May discolor some fabrics
  • INACTIVE INGREDIENT

    Inactive ingredients Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Fragrance, Water

  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    WATERLESS ANTI-BACTERIAL HAND CLEANSER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-001-088 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/07/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd528039793manufacture
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