Drugplain

Povidone Iodine Prep 10 g/100mL

Povidone Iodine · SOLUTION · Sion Biotext Medical Ltd

3 Recalls on Record
Plain English

Povidone Iodine Prep is a solution containing povidone iodine at 10 g/100mL, taken topical. Manufactured by Sion Biotext Medical Ltd.

Key Facts

Brand Name
Povidone Iodine Prep
Generic Name
Povidone Iodine
NDC Code (Product)
68786-010
Manufacturer
Sion Biotext Medical Ltd
Strength
10 g/100mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
M003
Drug Class
Antiseptic [EPC]
Marketing Start
05/06/2025

Recall History

3 Recalls on Record
Class II09/21/2017

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

TerminatedVoluntary: Firm initiated
Class II07/23/2021

Professional Disposables International, Inc

SubPotent: Out of Specification

TerminatedVoluntary: 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 use291 reports
endophthalmitis221 reports
nausea170 reports
drug ineffective166 reports
pain161 reports
rash158 reports
drug hypersensitivity145 reports
product use in unapproved indication124 reports
toxic anterior segment syndrome122 reports
c-reactive protein increased113 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 Prep used for?

Povidone Iodine Prep contains Povidone Iodine. It is a solution taken topical. Consult your doctor for specific uses.

Is Povidone Iodine Prep a controlled substance?

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

What is the generic name for Povidone Iodine Prep?

The generic name for Povidone Iodine Prep is Povidone Iodine. There are 11 other brand versions of Povidone Iodine.

What is the NDC code for Povidone Iodine Prep 10 g/100mL?

The NDC (National Drug Code) for Povidone Iodine Prep 10 g/100mL is 68786-010, listed by Sion Biotext Medical Ltd.

Product NDC

68786-010

Package NDC

68786-010-08

Other Povidone Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)