Label: SIMPLY RIGHT SPARKLING MIST- 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 August 12, 2013

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

    PURPOSE

    ANTIBACTERIAL

    USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN

    WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS RINSE WITH WATER

    STOP USING THE PRODUCT AND ASK A DOCTOR IF

    IRRITATION AND REDNESS DEVELOP AND LAST.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY  

  • DIRECTIONS

    SQUEEZE ONTO WET HANDS OR BODY SPONGE. WORK INTO A LATHER. WASH SKIN, RINSE AND DRY THOROUGHLY.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS:

    WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM CHLORIDE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE,ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, DMDM HYDANTOIN, CITRIC ACIE, TETRASODIUM EDTA, BLUE 1(CI 42090), RED 33 (CI 17200).

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT  SPARKLING MIST
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-808-24710 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2013
    Labeler - SAM'S WEST INC (051957769)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(68196-808)
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