Label: BACTI-STAT AE- triclosan solution 

  • Label RSS
  • NDC Code(s): 47593-170-26, 47593-170-31, 47593-170-32, 47593-170-56
  • Packager: Ecolab Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • Active ingredient

    Triclosan, 0.3%

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  • Purpose

    Antiseptic handwash

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  • Uses

    • for hand washing to decrease bacteria on the skin
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  • 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.

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  • Directions

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

    • for additional information, see Material Safety Data Sheet (MSDS)
    • for emergency medical information in USA and Canada, call 1.800.328.0026
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  • INACTIVE INGREDIENT

    ​Inactive ingredients water (agua), 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, FDC blue 1, FDC yellow 5

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  • QUESTIONS

    ​Questions? ​call 1.866.781.8787

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  • Principal Display Panel and Representative Label

    ECOLAB

    BACTI-STAT® AE

    NDC 47593-170-56

    Antimicrobial

    Hand Soap

    Active Ingredient: 0.3% Triclosan

    Net Contents: 1200 mL (40.6 US fl oz)

    6086289

    746445/8501/0410

    representative labelrepresentative label

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  • INGREDIENTS AND APPEARANCE
    BACTI-STAT AE 
    triclosan solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:47593-170
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Triclosan (Triclosan) Triclosan 3.06 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POTASSIUM COCOATE  
    ALCOHOL  
    GLYCERIN  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE  
    POTASSIUM STEARATE  
    EDETATE SODIUM  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    COCAMINE OXIDE  
    METHYLPARABEN  
    .ALPHA.-TOCOPHEROL ACETATE  
    CITRIC ACID MONOHYDRATE  
    ISOPROPYL ALCOHOL  
    PROPYLPARABEN  
    ALOE VERA LEAF  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47593-170-31 540 mL in 1 BOTTLE, PLASTIC
    2 NDC:47593-170-32 1000 mL in 1 BOTTLE, PLASTIC
    3 NDC:47593-170-26 1000 mL in 1 BOTTLE, PLASTIC
    4 NDC:47593-170-56 1200 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 07/14/1997
    Labeler - Ecolab Inc. (006154611)
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