Drugplain

Povidone Iodine 100 mg/mL

Povidone Iodine 10% · LIQUID · Pharma Nobis, LLC

10 Recalls on Record
Plain English

Povidone iodine 10% is a topical antiseptic liquid applied directly to the skin to help prevent infection in minor cuts, scrapes, and wounds. It is available over the counter without a prescription.

Key Facts

Brand Name
Povidone Iodine
Generic Name
Povidone Iodine 10%
NDC Code (Product)
82645-907
Manufacturer
Pharma Nobis, LLC
Strength
100 mg/mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M003
Drug Class
Antiseptic [EPC]
Marketing Start
01/01/2008

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 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 II08/04/2017

Degasa Sa De Cv

Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

TerminatedVoluntary: Firm initiated
Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Edge Pharma, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II02/15/2018

Medline Industries Inc

Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.

TerminatedVoluntary: Firm initiated
Class II04/22/2026

CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

OngoingVoluntary: Firm initiated
Class II07/23/2021

Professional Disposables International, Inc

SubPotent: Out of Specification

TerminatedVoluntary: Firm initiated
Class II04/22/2026

CareFusion 213, LLC

Lack of assurance of Sterility: potential product contamination

OngoingVoluntary: Firm initiated
Class II07/23/2021

Professional Disposables International, Inc

SubPotent: Out of Specification

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use292 reports
endophthalmitis222 reports
nausea170 reports
drug ineffective166 reports
pain161 reports
rash157 reports
drug hypersensitivity145 reports
product use in unapproved indication124 reports
toxic anterior segment syndrome122 reports
c-reactive protein increased114 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Antiseptic skin preparation

Dosage & Administration

Directions Apply locally as needed.

Warnings

Warnings For external use only. Do not use if allergic to iodine Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burn Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center Immediately Avoid excessive heat. Store at room temperature.

Frequently Asked Questions

What is Povidone Iodine used for?

Povidone iodine 10% is a topical antiseptic liquid applied directly to the skin to help prevent infection in minor cuts, scrapes, and wounds. It is available over the counter without a prescription.

Is Povidone Iodine a controlled substance?

Povidone Iodine is not classified as a controlled substance by the DEA.

What is the generic name for Povidone Iodine?

The generic name for Povidone Iodine is Povidone Iodine 10%. There are 9 other brand versions of Povidone Iodine 10%.

What is the NDC code for Povidone Iodine 100 mg/mL?

The NDC (National Drug Code) for Povidone Iodine 100 mg/mL is 82645-907, listed by Pharma Nobis, LLC.