BACTI-STAT AE- triclosan solution 
Ecolab Inc.

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 Facts

Active ingredient

Triclosan, 0.3%

Purpose

Antiseptic handwash

Uses

Warnings

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.

Directions

Other information

​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

​Questions? ​call 1.866.781.8787

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

BACTI-STAT AE 
triclosan solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-170
Route of Administration TOPICAL DEA Schedule     
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
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)

Revised: 9/2012
Document Id: bfc7d2d0-d06b-45ab-a66d-252ae0844cd0
Set id: a4e738e1-3aa6-4b8d-8b6a-ba3db433b623
Version: 2
Effective Time: 20120912
 
Ecolab Inc.