Label: HEALING WATERS SWEET PEA ANTIBACTERIAL HAND SOAP- 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 May 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                                        Purpose
    Triclosan 0.115%                                           Antibacterial
  • DESCRIPTION

    Uses

    For hand washing to decrease bacteria on skin
  • WARNINGS

    Warnings

    For external use only-hands.  Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
  • INDICATIONS & USAGE

    Directions

    • Wet hands
    • Apply palmful to hands
    • Scrub thoroughly
    • Rinse
    • For children under 6,use only under adult supervision.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water(Aqua), Sodium Laureth Sulfate, Cocamide DEA, Disodium EDTA, Citric Acid, Methylchloroisothiazolinone, Fragrance, Methylisothiazolinone, Sodium Chloride. May contain: FD and C Red No. 40, FD and C Yellow No. 5, FD and C Blue No. 1

  • PRINCIPAL DISPLAY PANEL

    labpicture

  • INGREDIENTS AND APPEARANCE
    HEALING WATERS SWEET PEA ANTIBACTERIAL HAND SOAP 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50593-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 80.97499 g  in 100 g
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12.0 g  in 100 g
    COCAMIDE DIETHANOLAMINE (UNII: 92005F972D) 5.0 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.08 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.15 g  in 100 g
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.04 g  in 100 g
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.04 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.2 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.000004 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.000002 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000004 g  in 100 g
    PEA (UNII: W4X7H8GYFM) 0.4 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50593-004-01480 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33302/10/2010
    Labeler - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)
    Registrant - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Xinzhixuan Daily-Use Co., Ltd.420438920manufacture
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