Label: ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS- triclosan 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 January 18, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.115 PERCENT

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    DO NOT GET INTO EYES.  IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

  • DIRECTIONS:

    • WET HANDS
    • APPLY PALMFUL TO  HANDS
    • SCRUB THOROUGHLY
    • RINSE
  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, LAURAMIDE DEA, COCAMIDOPROPYL BETAINE, HYDROLYZED VEGETABLE PROTEIN, SACCHAROMYCES,   POLYQUATERNIUM-7,  CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, TETRASODIUM EDTA, SODIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, FRAGRANCE, YELLOW 5 (CI 19140), RED 40 (CI 16035),  RED 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF MEMBER'S MARK ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS  
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-140-802.36 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/18/2011
    Labeler - SAM'S WEST INC. (051957769)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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