Label: HUSKY 575 FOAMING ANTISEPTIC HAND CLEANER- foaming antiseptic hand cleaner solution

  • 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 January 3, 2014

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  • ACTIVE INGREDIENT

    Triclosan 0.5% w/w.......Antibacterial Handwashing

  • INACTIVE INGREDIENT

    Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, Fragrance, Citric Acid, Polyquaternium-10, Aloe Barbadensis Leaf, Tocopheryl Acetate, Tetrasodium EDTA, DMDM Hydantoin, Green #3.

  • PURPOSE

    Handwash to help decrease bacteria on the skin.

  • WARNINGS

    For external use only.

    Do not use in the eyes. In case of eye contact, immediately flush with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • INDICATIONS & USAGE

    Handwash to help decrease bacteria on the skin.

    Do not use in the eyes. In case of eye contact, immediately flush with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    63779-340-09.jpg63779-340-09.jpg

  • PRINCIPAL DISPLAY PANEL

    63779-340-77.jpg63779-340-77.jpg

  • PRINCIPAL DISPLAY PANEL

    63779-340-17.jpg    63779-340-17.jpg

  • INGREDIENTS AND APPEARANCE
    HUSKY 575 FOAMING ANTISEPTIC HAND CLEANER 
    foaming antiseptic hand cleaner solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63779-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN20.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63779-340-771100 mL in 1 BOTTLE, PLASTIC
    2NDC:63779-340-093785 mL in 1 BOTTLE, PLASTIC
    3NDC:63779-340-1750 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2013
    Labeler - Canberra Corporation (068080621)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(63779-340) , analysis(63779-340) , pack(63779-340)