Label: 1014 FOAMING ANTIMICROBIAL - triclosan soap

  • NDC Code(s): 62257-014-01, 62257-014-03, 62257-014-05, 62257-014-06, view more
    62257-014-07, 62257-014-08, 62257-014-09, 62257-014-10, 62257-014-11, 62257-014-12, 62257-014-13, 62257-014-14, 62257-014-15, 62257-014-16, 62257-014-17, 62257-014-18, 62257-014-24, 62257-014-27, 62257-014-28, 62257-014-55
  • Packager: ABC Compounding Co., Inc.
  • 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 1, 2013

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

  • Drug Facts Box OTC-Active Ingredient Section

    Triclosan 0.3%

    Close
  • Drug Facts Box OTC-Purpose Section

    Antiseptic

    Close
  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

    Close
  • Drug Facts Box OTC-Warnings Section

    For external use only

    Close
  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

    Close
  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

    Close
  • Drug Facts Box OTC-Keep Out of Reach of Children Section

    if swallowed, get medical help or contact a Poison Control Center right away

    Close
  • Drug Facts Box OTC-Dosage & Administration Section


    wet hands and forearms

    apply 5 milliliters (teaspoonful) or palmful to hands and forearms

    scrub thoroughly for 1 minute and rinse

    Close
  • Drug Facts Box OTC-Inactive Ingredient Section

    water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, alcohol denat., propylene glycol, tetrasodium EDTA, PEG-75 lanolin,  boric acid, lauramine oxide, chloroxylenol, methylparaben, propylparaben, fragrance, aloe barbadensis, acid red 1, reactive green 12

    Close
  • 1014 Foaming Antimicrobial 6576 1 gallon bottle

    657641PSP.jpg  1014 Foaming Antimicrobial 1 gallon bottle image of bottle label

    Close
  • INGREDIENTS AND APPEARANCE
    1014 FOAMING ANTIMICROBIAL  
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62257-014
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BORIC ACID (UNII: R57ZHV85D4)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62257-014-06 1 in 1 BOX
    1 800 mL in 1 BAG
    2 NDC:62257-014-17 532 mL in 1 BOTTLE, PLASTIC
    3 NDC:62257-014-24 118 mL in 1 BOTTLE, PLASTIC
    4 NDC:62257-014-01 1200 mL in 1 CARTRIDGE
    5 NDC:62257-014-03 350 mL in 1 CARTRIDGE
    6 NDC:62257-014-05 540 mL in 1 BOTTLE, PLASTIC
    7 NDC:62257-014-07 700 mL in 1 BAG
    8 NDC:62257-014-09 2000 mL in 1 CARTRIDGE
    9 NDC:62257-014-10 1000 mL in 1 CARTRIDGE
    10 NDC:62257-014-11 1000 mL in 1 BOTTLE, PLASTIC
    11 NDC:62257-014-12 1000 mL in 1 BAG
    12 NDC:62257-014-13 800 mL in 1 BAG
    13 NDC:62257-014-14 3785 mL in 1 BOTTLE, PLASTIC
    14 NDC:62257-014-15 946 mL in 1 BOTTLE, PLASTIC
    15 NDC:62257-014-28 149 mL in 1 BOTTLE, PLASTIC
    16 NDC:62257-014-27 800 mL in 1 CARTRIDGE
    17 NDC:62257-014-55 208200 mL in 1 DRUM
    18 NDC:62257-014-08 1 in 1 BOX
    18 1000 mL in 1 BAG
    19 NDC:62257-014-16 236 mL in 1 BOTTLE, PLASTIC
    20 NDC:62257-014-18 50 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 05/01/2013
    Labeler - ABC Compounding Co., Inc. (003284353)
    Establishment
    Name Address ID/FEI Business Operations
    ABC Compounding Co., Inc. 003284353 manufacture(62257-014)
    Close