Label: ANTIBACTERIAL AMBER 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 March 15, 2011

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  • Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally

    Ask a doctor before use if you have deep puncture wounds or serious burns

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Triclosan 0.04%

  • Purpose

    Antibacterial

  • Uses

    for hand washing to eliminate bacteria and germs on the skin.

  • Warnings

    Warnings

    For external use only.

    Do not apply around eyes. Do not use in ears and mouth

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

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

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

    Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse.

  • Other information

    store at 20C (68F to 70F). May discolor fabrics.

  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamide DEA, Glycerin, Dipropylene Glycol, Sodium Chloride, Fragrance, PEG-250 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, FD C Yellow No. 6

  • PRINCIPAL DISPLAY PANEL

    LabelEnter section text here

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL AMBER HAND SOAP 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29860-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.04 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 77 mL  in 100 mL
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12 mL  in 100 mL
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 4 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) .70 mL  in 100 mL
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) .05 mL  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .10 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29860-002-27800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    Labeler - Ningbo United Group Import and Export Co. Ltd. (544900137)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo United Group Import and Export Co. Ltd.544900137manufacture
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