Product Description.:
BETADINE? 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.
INDICATIONS AND USAGE
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
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
PRECAUTIONS
General
No studies are available in patients with thyroid disorders therefore, caution is advised in using BETADINE 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.
ADVERSE REACTIONS
Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
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:
1. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze entire contents of bottle into a sterile prep cup.
2. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid repeat once.
3. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered repeat prep three (3) times.
4. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe.
5. 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.
HOW SUPPLIED
BETADINE 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions and supplied in 1 fl.oz. (30 mL) form sealed blue HDPE bottles (NDC #0065 0411 30). Twenty-four (24) bottles are packed in each shipper.
Store at 15-25?C (59-77?F).
Rx Only
Single use only
