Label: DEODORANT- triclocarban soap

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    53507-001-01, 53507-001-02, 53507-001-03, 53507-001-04, view more
    53507-001-05, 53507-001-06, 53507-001-07, 53507-001-08, 53507-001-09, 53507-001-10, 53507-001-11, 53507-001-12, 53507-001-13, 53507-001-14, 53507-001-15, 53507-001-16, 53507-001-17
  • Packager: Shanghai Kangyi Tourism Products Co., Ltd.
  • 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 26, 2014

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Triclocarban 0.29%

    Antibacterial

  • Use

    For hand washing to decrease bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    For external use only. Keep out of reach of children.

    Children should use only this product under adult supervision.

    Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Avoid contact with broken skin.

    When using this product, avoid contact with eyes. In case of eye contact, immediately flush eyes with water, call a doctor.

    keep out of reach of children

  • Directions

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

    Recommended for repeated use.

  • Inactive ingredients

    Sodium Palmate, Sodium Cocoate, Calcium Carbonate, Water, Glycerin, Fragrance, Sodium Chloride, Edetate Sodium, Etidronic Acid, Titanium Dioxide.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DEODORANT  
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53507-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y) TRICLOCARBAN0.29 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Sodium Palmate (UNII: S0A6004K3Z)  
    Sodium Cocoate (UNII: R1TQH25F4I)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Etidronic Acid (UNII: M2F465ROXU)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53507-001-0110 g in 1 PACKAGE
    2NDC:53507-001-0213 g in 1 PACKAGE
    3NDC:53507-001-0320 g in 1 PACKAGE
    4NDC:53507-001-0430 g in 1 PACKAGE
    5NDC:53507-001-0535 g in 1 PACKAGE
    6NDC:53507-001-0654 g in 1 PACKAGE
    7NDC:53507-001-0760 g in 1 PACKAGE
    8NDC:53507-001-0875 g in 1 PACKAGE
    9NDC:53507-001-0985 g in 1 PACKAGE
    10NDC:53507-001-1014.17 g in 1 PACKAGE
    11NDC:53507-001-1121.26 g in 1 PACKAGE
    12NDC:53507-001-1228.35 g in 1 PACKAGE
    13NDC:53507-001-1342.52 g in 1 PACKAGE
    14NDC:53507-001-1471 g in 1 PACKAGE
    15NDC:53507-001-1599 g in 1 PACKAGE
    16NDC:53507-001-16113 g in 1 PACKAGE
    17NDC:53507-001-17142 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/24/2012
    Labeler - Shanghai Kangyi Tourism Products Co., Ltd. (531054513)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kangyi Tourism Products Co., Ltd.531054513manufacture(53507-001)