Betadine

Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas:

2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:

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.

A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log₁₀ reduction of 3.05 log₁₀ units in total aerobes at 10 minutes following prepping the skin with BETADINE® 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log₁₀ units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log₁₀ reduction by the iodine complex compared with the control solution of 1.47 log₁₀ units at 10 minutes and 1.79 log₁₀ units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms per square cm.

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).

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

FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.

Safety and effectiveness in pediatric patients have not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.

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.

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 #42254-006-30).

Store at 15-25°C (59-77°F).

Rx Only

Single use only

Manufactured for:

Alcon Laboratories, Inc.

Fort Worth, TX 76134

Manufactured by:

Catalent Pharma Solutions, LLC

Woodstock, IL 60098

Relabeled by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

BETADINE® is a registered trademark of The Purdue Frederick Company.

9002984-1007

NDC 42254-006-30

Betadine^® 5%

Sterile Ophthalmic Prep Solution

(povidone-iodine

ophthalmic solution)

For Pre-Operative Prep and

Irrigation of the Ocular and

Periocular Surfaces

Flush eye thoroughly with

sterile saline solution after

each use.

Rx Only

1 Fl. Oz. (30 mL)