Label: KIWI CRATE LIQUID HAND- triclosan soap

  • 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 6, 2014

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  • ACTIVE INGREDIENT

    Active ingredient:
    Triclosan 0.3%
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses: Hand soap to help decrease bacteria on the skin with rinsing by water after use. Recommended for repeated use.

  • WARNINGS

    Warnings: For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes.

    Do not use in ears or mouth.
    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

  • STOP USE

    Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions: Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.                                                                                                                                                                          
    Other information: Do not store in temperature over 118 F.  

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Sodium Alkyl Ether Sulphate, Cocamidopropyl Betaine, Ammonium Lauryl Sulphate, Disodium Laureth Sulfosuccinate, Cocamide DEA, Sodium Chloride, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Disodium EDTA, Citric Acid, FD&C Red NO.4, FD&C Red NO.33

  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INGREDIENTS AND APPEARANCE
    KIWI CRATE LIQUID HAND 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69034-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C12-15 PARETH-3 SULFATE (UNII: 19Q4RW8UWP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69034-001-1515 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/06/2014
    Labeler - Kiwi Crate (030884591)
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