Label: BACTI-STAT AE- triclosan solution

  • NDC Code(s): 47593-170-26, 47593-170-31, 47593-170-32, 47593-170-41, view more
    47593-170-56, 47593-170-59
  • Packager: Ecolab 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 October 19, 2016

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

  • Active ingredient

    Triclosan, 0.3%

    Close
  • Purpose

    Healthcare personnel handwash

    Close
  • Uses

    • healthcare personnel handwash
    Close
  • Warnings

    • For external use only

    Do not use

    • in eyes

    When using this product

    • discontinue use if irritation and redness develop

    Stop use and ask a doctor if

    • skin irritation or redness persists for more than 72 hours.

    ​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    • wet skin and spread a small amount on hands and forearms
    • scrub well, rinse thoroughly and dry
    Close
  • Other information

    • for additional information, see Material Safety Data Sheet (MSDS)
    • for emergency medical information in USA and Canada, call 1.800.328.0026
    • for emergency medical information worldwide, call 1 651 222 5352 (in the USA)
    Close
  • INACTIVE INGREDIENT

    ​Inactive ingredients water, potassium cocoate, SD alcohol 40-B, glycerin, cocamidopropyl PG-dimonium chloride phosphate, potassium stearate, tetrasodium EDTA, hydroxyethylcellulose, fragrance, cocamine oxide, methylparaben, tocopheryl acetate, citric acid, isopropyl alcohol, propylparaben, aloe barbadensis leaf juice, FD&C blue 1, FD&C yellow 5

    Close
  • QUESTIONS

    ​Questions? ​call 1.866.781.8787

    Close
  • Principal Display Panel and Representative Label

    ECOLAB

    NDC 47593-170-31

    BACTI-STAT AE®

    Antimicrobial Hand Soap

    Formulated with Aloe Vera & Vitamin E

    to promote skin health

    Healthcare personnel handwash

    Active Ingredient: 0.3% Triclosan

    6060116

    Net Contents: 540 mL (18 fl oz)

    Ecolab · 370 Wabasha Street N ·
    St Paul MN 55102-1390 USA
    © 2012 Ecolab USA Inc · All rights reserved
    Made in United States
    www.ecolab.com · 704451/8500/1012
    SDS-IN-1633

    image description

    Close
  • INGREDIENTS AND APPEARANCE
    BACTI-STAT AE 
    triclosan solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-170
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 3.06 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47593-170-31 540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2012
    2 NDC:47593-170-32 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2012
    3 NDC:47593-170-26 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2012
    4 NDC:47593-170-56 1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/12/2009 04/27/2016
    5 NDC:47593-170-41 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/22/2013 04/27/2016
    6 NDC:47593-170-59 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/22/2013 04/27/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 07/14/1997
    Labeler - Ecolab Inc. (006154611)
    Close