Label: SIMPLY RIGHT BODY CARE ANTIBACTERIAL- 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 October 25, 2012

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.115%

    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 IMMEDIATELY.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

  • DIRECTIONS

    USE REFILL TO FILL PUMP BOTTLE. FROM PUMP BOTTLE, APPLY SOAP TO WET HANDS, RUB THOROUGHLY AND RINSE WELL.

  • INACTIVE INGREDIENTS

    WATER (AQUA), SODIUM LAURETH SULFATE, LAURAMIDE DEA, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, POLYQUATERNIUM-7, SACCHAROMYCES, HYDROLYZED VEGEATBLE PROTEIN, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, TETRASODIUM EDTA, SODIUM CHLORIDE, FRAGRANCE (PARFUM), DMDM HYDANTOIN, CITRIC ACID, RED 33 (CI 17200), BLUE 1 (CI 42090).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT BODY CARE  ANTIBACTERIAL
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-145-802360 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/25/2012
    Labeler - SAM'S WEST INC. (051957769)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68196-145)
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