Drugplain

Povidone Iodine Prep Pad 10 mg/100mL

Povidone-Iodine · SWAB · Jianerkang Medical Co., Ltd

3 Recalls on Record
Plain English

Povidone Iodine Prep Pad is a swab containing povidone-iodine at 10 mg/100mL, taken topical. Manufactured by Jianerkang Medical Co., Ltd.

Key Facts

Brand Name
Povidone Iodine Prep Pad
Generic Name
Povidone-Iodine
NDC Code (Product)
34645-4008
Manufacturer
Jianerkang Medical Co., Ltd
Strength
10 mg/100mL
Dosage Form
SWAB
Route
TOPICAL
Marketing Status
Application #
M005
Drug Class
Antiseptic [EPC]
Marketing Start
01/01/2010

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 use268 reports
endophthalmitis172 reports
drug ineffective161 reports
nausea153 reports
pain150 reports
rash148 reports
drug hypersensitivity129 reports
product use in unapproved indication124 reports
confusional state112 reports
type 2 diabetes mellitus112 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 Pad used for?

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

Is Povidone Iodine Prep Pad a controlled substance?

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

What is the generic name for Povidone Iodine Prep Pad?

The generic name for Povidone Iodine Prep Pad is Povidone-Iodine. There are 12 other brand versions of Povidone-Iodine.

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

The NDC (National Drug Code) for Povidone Iodine Prep Pad 10 mg/100mL is 34645-4008, listed by Jianerkang Medical Co., Ltd.