RxNorm Names

Review RxNorm Normal Forms

BACTI-STAT AE (triclosan) solution
[Ecolab Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a4e738e1-3aa6-4b8d-8b6a-ba3db433b623

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient

Triclosan, 0.3%

Purpose

Antiseptic handwash

Uses

for hand washing to decrease bacteria on the skin

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.

Directions

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

Other information

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

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 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 (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
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: 09/2012

Document Id: bfc7d2d0-d06b-45ab-a66d-252ae0844cd0

Set id: a4e738e1-3aa6-4b8d-8b6a-ba3db433b623

Version: 2

Effective Time: 20120912

Ecolab Inc.

Daily Med

Current Medication Information

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