Drugplain

Isopropyl Alcohol 70 mL/100mL

Isopropyl Alcohol · LIQUID · Topco Associates LLC

10 Recalls on Record
Plain English

Isopropyl alcohol 70% is a topical antiseptic liquid used to disinfect skin before injections or medical procedures and to clean minor cuts and wounds. It is available over-the-counter without a prescription.

Key Facts

Brand Name
Isopropyl Alcohol
Generic Name
Isopropyl Alcohol
NDC Code (Product)
76162-845
Manufacturer
Topco Associates LLC
Strength
70 mL/100mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M003
Marketing Start
03/08/2019

Recall History

10 Recalls on Record
Class II01/17/2023

Fisher Scientific Co., LLC

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

OngoingVoluntary: Firm initiated
Class II06/13/2013

CareFusion 213, LLC

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

TerminatedVoluntary: Firm initiated
Class II08/25/2023

CareFusion 213, LLC

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

CompletedVoluntary: Firm initiated
Class I03/19/2021

CareFusion 213, LLC

Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

TerminatedVoluntary: Firm initiated
Class II03/04/2013

CareFusion 213, LLC

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

TerminatedVoluntary: Firm initiated
Class I03/03/2022

Tennessee Technical Coatings, Corp.

Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.

TerminatedVoluntary: Firm initiated
Class III08/25/2025

Consumer Product Partners, LLC

Cross Contamination with Other Products.

OngoingVoluntary: Firm initiated
Class II12/15/2022

Frenda Corporation

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class III08/25/2025

Consumer Product Partners, LLC

Cross Contamination with Other Products.

OngoingVoluntary: Firm initiated
Class II03/03/2022

Tennessee Technical Coatings, Corp.

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,908 reports
completed suicide5,398 reports
drug abuse5,228 reports
overdose1,993 reports
confusional state1,866 reports
fatigue1,782 reports
death1,770 reports
vomiting1,770 reports
pain1,768 reports
rash1,653 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use first aid to help prevent the risk of infection in: minor cuts scrapes burns

Dosage & Administration

Directions clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

Warnings

Warnings For external use only Flammable Keep away from fire or flame, heat, spark, electrical Do not use as a fuel source

Frequently Asked Questions

What is Isopropyl Alcohol used for?

Isopropyl alcohol 70% is a topical antiseptic liquid used to disinfect skin before injections or medical procedures and to clean minor cuts and wounds. It is available over-the-counter without a prescription.

Is Isopropyl Alcohol a controlled substance?

Isopropyl Alcohol is not classified as a controlled substance by the DEA.

What is the generic name for Isopropyl Alcohol?

The generic name for Isopropyl Alcohol is Isopropyl Alcohol. There are 9 other brand versions of Isopropyl Alcohol.

What is the NDC code for Isopropyl Alcohol 70 mL/100mL?

The NDC (National Drug Code) for Isopropyl Alcohol 70 mL/100mL is 76162-845, listed by Topco Associates LLC.