Povidone-iodine

FDA label, Alcon Laboratories, Inc., ophthalmic, effective 2022-06-29. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Antiseptic

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

DOSAGE AND ADMINISTRATION: While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided. BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: BETADINE* 5% Sterile Ophthalmic Prep Solution is used as follows: Make sure container is intact before use.

While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE* 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe. After the BETADINE* 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.

Contraindications

CONTRAINDICATIONS: Do not use on individuals known to be sensitive to iodine, or other components of this product.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for povidone-iodine. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy: Animal reproduction studies have not been conducted with BETADINE* 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE* 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.

Lactation

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Breastfeeding (LactMed)

The use of povidone-iodine in the mother near term and during breastfeeding increases breastmilk iodine levels and can cause transient hypothyroidism in breastfed infants, especially in geographic areas that are iodine deficient. Maternal exposure to povidone-iodine near term can sometimes interfere with thyroid studies done as a part of newborn screening tests. Although iodine from povidone-iodine is minimally absorbed through intact adult skin, exposure of mothers who are or will be breastfeeding to povidone-iodine should be minimized by using lower concentrations of povidone-iodine, applying it to the smallest possible surface areas of the body, shortening contact time, and avoiding repeated applications.

Alternatives LactMed suggests considering:
Source: LactMed: Povidone-Iodine (NICHD, public domain)Revised Apr 15, 2026

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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