Label: JABONITO FRESH- 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 February 16, 2016

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  • PURPOSE

    PURPOSE

    Antibacterial

    For washing to decrease bacteria on the skin.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Triclosan 0.05%

  • WARNINGS

    WARNING

    For external use only

  • INDICATIONS & USAGE

    WHEN USING THIS PRODUCT

    Avoid contact with eyes. If contact occurs rinse thoroughly with water.

    STOP USE and contact doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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

  • INSTRUCTIONS FOR USE

    DIRECTIONS

    Wet bar with water.

    Lather vigirously and wash skin.

    Rinse and dry thoroughly.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Titanium Dioxide
    Water
    Talc
    Fragrance
    Sodium Tallowate

    FD & C Blue No.1

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    Registro sanitario: Guatemala PT-66360

  • QUESTIONS

    QUESTIONS?

    1-801-0026-227

  • Dosage and Administration

    Dosage and administration

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    JABONITO FRESH 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.0005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    TALC (UNII: 7SEV7J4R1U)  
    ABRONIA FRAGRANS WHOLE (UNII: LXC8S3ELIE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-100-014 g in 1 BOX; Type 0: Not a Combination Product01/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/26/2016
    Labeler - Industria LA Popular SA (846044576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Industria LA Popular SA846044576manufacture(62476-100)
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