Povidone-iodine
FDA Label NDC 34645-4001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Province Jianerkang Medical Dressing Co. ,ltd. for the product Povidone-iodine (NDC 34645-4001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Package Label.Principal Display Panel

Cat.40000-050      NDC 34645-4001-4     Qty. 3ea

Povidone-Iodine Swab Stick

Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat

Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine

For External Use Only

Distributed by:

Cardinal Health

Dublin, OH 43017 USA

Made in China

Image of Pouch Label

Pouch Label (Pouch)

Pouch Label (Pouch)

Otc - Active Ingredient

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

Otc - Purpose

Purpose

Antiseptic

Otc - When Using

Uses

Health-care antiseptic for preparation of the skin prior to surgery

First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine

* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.

Otc - Stop Use

Discontinue useIf irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

Otc - Ask Doctor

Consult a doctor in case of* deep or puncture wounds * animal bites * serious burns.
Stop use and consult a doctorif the condition persists or gets worse.

Indications & Usage

DirectionsClean the affected areaApply product on the area 1-3 times daily and discardMay be covered with a sterile bandage when dry
DirectionsFor preparation of the skin prior to surgery* clean the affected area * remove swab by stick* apply to the operative site prior to surgeryFor use as a first aid antiseptic* clean the affected area* apply a small amount of this product on the area 1-3 times daily* may be covered with a sterile bandage* if bandaged, let dry first

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Storage And Handling

Other informationStore at room temperature: 15o - 30o C (59o-86o F)

Inactive Ingredient

Inactive ingredients

citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

* Please review the disclaimer below.