PREGNANCY SECTION.

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 pregnant woman or can affect reproductive capacity. BETADINE 5% Sterile Ophthalmic Prep Solution should only be used on pregnant woman if clearly needed.

WARNINGS SECTION.

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

ADVERSE REACTIONS SECTION.

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY: placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed 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 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/cm2.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION: Povidone-Iodine is 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 sterile dark brown solution stabilized by glycerin. Inactive Ingredients: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.

DOSAGE & ADMINISTRATION SECTION.

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 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. To open, COMPLETELY TWIST OFF TAB, do not pull off.Gently pour entire contents of bottle into sterile prep cup. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE 5% Sterile Ophthalmic Prep Solution using sterile bulb syringe.After the BETADINE 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off.. Gently pour entire contents of bottle into sterile prep cup. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE 5% Sterile Ophthalmic Prep Solution using sterile bulb syringe.. After the BETADINE 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.

GENERAL PRECAUTIONS SECTION.

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.

GERIATRIC USE SECTION.

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

HOW SUPPLIED SECTION.

HOW SUPPLIED: BETADINE 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions, and supplied in fl oz (30 mL) form sealed blue HDPE bottles. Twenty-four (24) bottles are packed in each shipper.NDC 0065-0411-30 Store at 15C to 25C (59F-77F). Rx Only Single-use only ALCON(R) Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134Manufactured by: Catalent Pharma Solutions, LLC Woodstock, IL 60098BETADINE is registered trademark of Purdue Products L.P.WSTW-AC6024-642R00.

INDICATIONS & USAGE SECTION.

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).

NURSING MOTHERS SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. NDC 0065-0411-30 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 Fl. Oz. (30 mL) Alcon(R) Novartis company Indications: 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. Warning: For external use only.NOT for intraocular injection or irrigation. Read package insert for full use and directions and precautions. Storage: 15- 25C (59- 77F). (C)2014 Novartis Active Ingredient: povidone-iodine 5% (0.5% available iodine). Inactive Ingredients: purified water, citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide. Single use only. Manufactured for: Alcon Laboratories, Inc.Fort Worth, Texas 76134 Manufactured by:Catalent Pharma Solutions, LLCWoodstock, IL 60098 BETADINE Reg. TM of Purdue Products L.P. Alcon(R) Alcon Laboratories, Inc.6201 South FreewayFort Worth, Texas 76134 9008803-0514 Rx only NDC 0065-0411-30 Betadine(R) 5% Sterile Ophthalmic Prep Solution(povidone-iodine ophthalmic solution)(0.5% available iodine) fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon(R) Mfd. forAlcon Laboratories, Inc.Fort Worth, Texas 76134 USA H12639-0514.

PEDIATRIC USE SECTION.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.

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.. Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.. 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 pregnant woman or can affect reproductive capacity. BETADINE 5% Sterile Ophthalmic Prep Solution should only be used on pregnant woman if clearly needed.. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE 5% Sterile Ophthalmic Prep Solution, decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.