Drugplain

First Aid Antiseptic 10 mg/mL

POVIDONE-IODINE · SOLUTION · Meijer, Inc.

10 Recalls on Record
Plain English

First Aid Antiseptic is a topical antiseptic solution containing povidone-iodine that you can buy over the counter to help prevent infection in minor cuts, scrapes, and wounds. You apply it directly to the skin at the affected area.

Key Facts

Brand Name
First Aid Antiseptic
Generic Name
POVIDONE-IODINE
NDC Code (Product)
41250-720
Manufacturer
Meijer, Inc.
Strength
10 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
M003
Drug Class
Antiseptic [EPC]
Marketing Start
08/12/2011

Recall History

10 Recalls on Record
Class II09/11/2024

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

OngoingVoluntary: Firm initiated
Class II11/26/2013

Humco Holding Group, Inc

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

TerminatedVoluntary: Firm initiated
Class II02/13/2025

World Perfumes Inc.

Defective Container: broken or leaking bottles.

OngoingVoluntary: Firm initiated
Class II08/05/2024

Zeco LLC

CGMP Deviations: sterile water not used for production

CompletedVoluntary: Firm initiated
Class II09/09/2021

Vi-Jon, Inc.

Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces

TerminatedVoluntary: Firm initiated
Class II03/02/2022

Vi-Jon, Inc.

Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.

TerminatedVoluntary: Firm initiated
Class II02/20/2019

Vi-Jon, Inc.

Cross Contamination: Presence of IPA in finished product.

TerminatedVoluntary: Firm initiated
Class II06/15/2022

Vi-Jon, LLC

Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.

TerminatedVoluntary: Firm initiated
Class II06/14/2012

Dukal Corp.

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

TerminatedVoluntary: Firm initiated
Class II02/07/2022

Tsm Brands LLC

Labeling - product contains undeclared ethyl alcohol

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

toxicity to various agents5,959 reports
completed suicide5,424 reports
drug abuse5,273 reports
overdose2,036 reports
confusional state1,930 reports
pain1,893 reports
fatigue1,891 reports
vomiting1,878 reports
off label use1,864 reports
death1,797 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses 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

Adverse Reactions

Adverse Reaction DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction PID 314823

Frequently Asked Questions

What is First Aid Antiseptic used for?

First Aid Antiseptic is a topical antiseptic solution containing povidone-iodine that you can buy over the counter to help prevent infection in minor cuts, scrapes, and wounds. You apply it directly to the skin at the affected area.

Is First Aid Antiseptic a controlled substance?

First Aid Antiseptic is not classified as a controlled substance by the DEA.

What is the generic name for First Aid Antiseptic?

The generic name for First Aid Antiseptic is POVIDONE-IODINE. There are 12 other brand versions of POVIDONE-IODINE.

What is the NDC code for First Aid Antiseptic 10 mg/mL?

The NDC (National Drug Code) for First Aid Antiseptic 10 mg/mL is 41250-720, listed by Meijer, Inc..