RxNorm Names

Not yet provided

ECOLAB (alcohol) solution
[Ecolab Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c69b563d-ea9d-4ebc-b9ca-b84bd4e0de85

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

Ethyl Alcohol 62% v/v

Purpose

Antiseptic handwash

Uses

For handwashing to decrease bacteria on skin

Warnings

For external use only
Flammable, keep away from fire or flame, heat sparks and sources of static discharge.

Do no use

In eyes

When using this product

If in eyes, rinse promptly and thoroughly with water
Discontinue use if irritation and redness develop

Stop use and ask a doctor if

Skin irritation or redness occurs 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

Apply product onto hands, spread thoroughly and rub until dry

Other information

for additional information, see Material Safety Data Sheet (MSDS)
for emergency medical information in USA, call 1 800 328 0026

Inactive ingredients water (aqua), PEG-32, cetyl alcohol, glycerin, tetrahydroxyethyl ethylenediamine, meadowfoam seed oil, acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, isopropyl palmitate, cyclohexasiloxane, tert-butyl alcohol, tocopheryl acetate, dimethicone, titanium dioxide, aloe barbadensis leaf juice, panthenol, dentaonium benzoate, fragrance

Questions? call 1 866 781 8787

Principal Display Panel and Representative Label

ECOLAB

NDC 47593-488-26

Advanced Gel Hand Sanitizer

CHG Compatible

Active Ingredient: 62% Ethyl Alcohol

6030390

Net Contents: 1000 mL (33.8 fl oz)

751025/8500/0912

representative label

ECOLAB
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-488
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (ALCOHOL)	ALCOHOL	540.02 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
POLYETHYLENE GLYCOL 1450
CETYL ALCOHOL
GLYCERIN
ETHYLENEDIAMINE TETRAETHANOL
MEADOWFOAM SEED OIL
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)
CYCLOMETHICONE 5
ISOPROPYL PALMITATE
CYCLOHEXANE
TERT-BUTYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
DIMETHICONE
TITANIUM DIOXIDE
ALOE VERA LEAF
PANTHENOL
DENATONIUM BENZOATE

Packaging
#	Item Code	Package Description
1	NDC:47593-488-33	118 mL in 1 BOTTLE, PLASTIC
2	NDC:47593-488-31	540 mL in 1 BOTTLE, PLASTIC
3	NDC:47593-488-32	1000 mL in 1 BOTTLE, PLASTIC
4	NDC:47593-488-26	1000 mL in 1 POUCH
5	NDC:47593-488-49	37 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	11/30/2012

Labeler - Ecolab Inc. (006154611)

Revised: 12/2012

Document Id: 804df882-c852-461c-a5ec-f2547f46bf88

Set id: c69b563d-ea9d-4ebc-b9ca-b84bd4e0de85

Version: 1

Effective Time: 20121203

Ecolab Inc.

Daily Med

Current Medication Information

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