Label: SIMPLY RIGHT BODY CARE- 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 July 4, 2013

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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

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

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

  • 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, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, DECYL GLUCOSIDE, POLYQUATERNIUM-7, HYDROLYZED VEGETABLE PROTEIN, PEG-120 METHYL GLUCOSE DIOLEATE, PEG-7 GLYCERYL COCOATE, PEG-8, FRAGRANCE (PARFUM), CAMELLIA SINENSIS (GREEN TEA) EXTRACT, SACCHAROMYCES, ALOE BARBADENSIS LEAF POWDER, TOCOPHERYL ACETATE, RETINYL PALMITATE, NIACINAMIDE, ASCORBYL PALMITATE, TERASODIUM EDTA, DMDM HYDANTOIN, RED 33 (CI 17200), BLUE 1 (CI 42090).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT BODY CARE 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-147
    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)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-147-802360 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/03/2013
    Labeler - SAM'S WEST INC. (051957769)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68196-147)
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