Indications
BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Contraindications
Do not use on individuals known to be sensitive to iodine, or other components of this product.
Warnings and precautions
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Pregnancy and breastfeeding
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.
Adverse reactions
Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Composition
- Active ingredients
- POVIDONE-IODINE 5%
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA018634.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Betadine
- Active substance
- povidone-iodine
- Pharmacologic class
- Antiseptic
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Alcon Pharms LTD
- Status
- Prescription
- FDA approval
- 17 Dec 1986
- Application
- NDA018634-001