Label: ANTIBACTERIAL SPARKLING MIST- triclosan solution

  • 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 June 17, 2011

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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 DOCTOR IF

    IRRITATION AND REDNESS DEVELOP.

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

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

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-8, FRAGRANCE, GLYCERIN, ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE, POLYQUATERNIUM-10, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE, DMDM HYDANTOIN, CITRIC ACID, PROPYLENE GLYCOL, NIACINAMIDE, HIBISCUS, SADARIFFA 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, SODIUM CHLORIDE, BLUE1, RED 33

  • PRINCIPAL DISPLAY PANEL

    Image of label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  SPARKLING MIST
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-8 DIOLEATE (UNII: 6JR5A7273E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    INDELOXAZINE HYDROCHLORIDE (UNII: 15QZ6NE84E)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GINGER (UNII: C5529G5JPQ)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-804-24720 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/17/2011
    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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