RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eeb4f114-5cf4-4330-9bc0-197cd16a3946

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

Healthcare personnel handwash

Uses

healthcare personnel handwash

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 and redness persist for more than 72 hours

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

Direction

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
For emergency medical information worldwide, call 1-651-222-5352 (in the USA)

Inactive ingredients water, potassium cocoate, SD alcohol 40-B, glycerin, potassium stearate, cocamidopropyl PG-dimonium chloride phosphate, tetrasodium EDTA, hydroxyethylcellulose, cocamine oxide, fragrance, methylparaben, tocopheryl acetate, citric acid, isopropyl alcohol, propylparaben, aloe barbadensis leaf juice, DC red 33

Questions? call 1 866 781 8787

Principal Display Panel and Representative Label

ECOLAB®

NDC 47593-178-31

DIN 00779237

BACTI-STAT®

Antimicrobial Hand Soap

Healthcare Personnel Handwash

Active Ingredient: 0.3% Triclosan

6048722

Net Contents: 540 mL (18 fl oz)

Ecolab

370 Wabasha St N

St Paul MN 55102-1390 USA

representative label

BACTI-STAT
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-178
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
POTASSIUM STEARATE
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
EDETATE SODIUM
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%)
COCAMINE OXIDE
METHYLPARABEN
ALPHA-TOCOPHEROL ACETATE
CITRIC ACID MONOHYDRATE
ISOPROPYL ALCOHOL
PROPYLPARABEN
ALOE VERA LEAF
D&C RED NO. 33

Packaging
#	Item Code	Package Description
1	NDC:47593-178-11	3780 mL in 1 BOTTLE, PLASTIC
2	NDC:47593-178-33	118 mL in 1 BOTTLE, PLASTIC
3	NDC:47593-178-31	540 mL in 1 BOTTLE, PLASTIC
4	NDC:47593-178-32	1000 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	01/23/1997

Labeler - Ecolab Inc. (006154611)

Revised: 02/2013

Document Id: 5831cd36-c41a-49f8-b593-cb9ce0fe99eb

Set id: eeb4f114-5cf4-4330-9bc0-197cd16a3946

Version: 2

Effective Time: 20130212

Ecolab Inc.

Daily Med

Current Medication Information

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