Ecolab 589.4 mg/mL

Alcohol · SOLUTION · Ecolab Inc.

10 Recalls on RecordCurrently in Shortage

Plain English

Ecolab is a solution containing alcohol at 589.4 mg/mL, taken topical. Manufactured by Ecolab Inc..

Key Facts

Brand Name: Ecolab
Generic Name: Alcohol
NDC Code (Product): 47593-487
Manufacturer: Ecolab Inc.
Strength: 589.4 mg/mL
Dosage Form: SOLUTION
Route: TOPICAL
Marketing Status
Application #: 505G(a)(3)
Marketing Start: 11/28/2012

Recall History

10 Recalls on Record

Class II02/06/2019

Ecolab Inc

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

TerminatedVoluntary: Firm initiated

Class II02/06/2019

Ecolab Inc

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

TerminatedVoluntary: Firm initiated

Class II11/09/2018

Ecolab Inc

Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

TerminatedVoluntary: Firm initiated

Class II02/06/2019

Ecolab Inc

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

TerminatedVoluntary: Firm initiated

Class III05/10/2019

Ecolab Inc

Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

TerminatedVoluntary: Firm initiated

Class II02/06/2019

Ecolab Inc

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

TerminatedVoluntary: Firm initiated

Class III12/02/2016

Ecolab, Inc.

Subpotent Drug

TerminatedVoluntary: Firm initiated

Class II11/09/2018

Ecolab Inc

Labeling: Label mix-up - the label on the product may not match the formula in the bottle.

TerminatedVoluntary: Firm initiated

Class II07/30/2020

Ecolab Inc

Discoloration and Presence of Foreign Substance

TerminatedVoluntary: Firm initiated

Class III02/12/2016

Ecolab Inc

Subpotent drug

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents5,928 reports

completed suicide5,410 reports

drug abuse5,271 reports

overdose1,901 reports

death1,617 reports

intentional overdose1,542 reports

suicide attempt1,342 reports

cardio-respiratory arrest1,339 reports

drug dependence905 reports

somnolence905 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For handwashing to decrease bacteria on the skin Recommended for repeated use.

Dosage & Administration

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

Warnings

Warnings For external use only Do not 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.

Frequently Asked Questions

What is Ecolab used for?

Ecolab contains Alcohol. It is a solution taken topical. Consult your doctor for specific uses.

Is Ecolab a controlled substance?

Ecolab is not classified as a controlled substance by the DEA.

What is the generic name for Ecolab?

The generic name for Ecolab is Alcohol. There are 12 other brand versions of Alcohol.

What is the NDC code for Ecolab 589.4 mg/mL?

The NDC (National Drug Code) for Ecolab 589.4 mg/mL is 47593-487, listed by Ecolab Inc..

Product NDC

47593-487

Package NDC

Other Alcohol Brands

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)