Label: AROMAFIELDS PLUMERIA SCENTED ANTIBACTERIAL HAND WASH- 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 9, 2010

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients                        Purpose

    Triclosan 0.025% ..........................Antibacterial

  • PURPOSE

    Uses

    For handwashing to decrease bacteria on the skin
  • WARNINGS

    Warnings:

    For external use only


    When using this product

    avoid contact with eyes. In case of eye contact, flush with water


  • STOP USE

    Stop use and ask a doctor if irritation and redness develop

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center right away


  • DOSAGE & ADMINISTRATION

    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), Ammonium Lauryl Sulfate, Ammonium chloride, Lauramide DEA, DMDM Hydantoin, fragrance, Citric Acid, Tertrasodium EDTA, FDandC Blue 1, FDandC Yello 5, FDandC Red 40.

  • SPL UNCLASSIFIED SECTION

    Formulated exclusively and distributed by:
    Enchante Accessories, Inc.
    New York, NY 10016
    Not Tested On Animals. For adult use only.
    Designed in the USA
    Made in China
    16.9 fl.oz./500ml
  • PRINCIPAL DISPLAY PANEL

    Cranberry Vanilla

    scented

    Antibacterial

    Hand Sanitizer

    3.1 fl. oz. / 90ml

  • PRINCIPAL DISPLAY PANEL

    handwashlabel
  • PRINCIPAL DISPLAY PANEL

    handwashdrugpanel

  • INGREDIENTS AND APPEARANCE
    AROMAFIELDS PLUMERIA SCENTED ANTIBACTERIAL HAND WASH 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.025 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-400-01500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/07/2010
    Labeler - Enchante Accessories (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Blue Dream Cosmetic Co., Ltd.529047234manufacture
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