Povidone-Iodine Prep Sterile

POVIDONE-IODINE TOPICAL HUMAN OTC DRUG

Povidone-Iodine Prep Sterile is an FDA drug label for the active ingredient POVIDONE-IODINE manufactured by Changzhou Maokang Medical Products Co., Ltd administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231213.

Generic name
POVIDONE-IODINE
Manufacturer
Changzhou Maokang Medical Products Co., Ltd
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
59050-658
Application
505G(a)(3)
Label effective
20231213

Active ingredients

Active ingredient Povidone-Iodine USP 10% Purpose Antiseptic

Indications & Usage

Use For preparation prior to surgery Helps to reduce bacteria that can potentially cause skin infection.

Dosage & Administration

Directions Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Contraindications

Not available.

Warnings

Warnings For external use only. Do not apply to persons allergic to iodine Do not use in the eyes Ask a doctor before use if injuries are • deep wounds • puncture wounds • serious burns Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours • infection occurs Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation. Keep out of reach of children. If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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