Label: SIMPLY RIGHT BODY CARE 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 14, 2013

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

    PURPOSE

    ANTIBACTERIAL

  • USE

    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 THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION AND REDNESS DEVELOPS AND LASTS.

    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 (PARFUM), GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS SABDARIFFA FLOWER EXTRACT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, TETRASODIUM EDTA, BLUE 1 (CI 42090), RED 33 (CI 17200).

  • LABEL COPY

    IMAGE OF TH ELABEL

  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT BODY CARE  SPARKLING MIST
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-809
    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)  
    ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINGER (UNII: C5529G5JPQ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    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:68196-809-24710 mL in 1 BOTTLE, PLASTIC08/12/2013
    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(68196-809)
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