Drug Facts
Composition & Profile
Identifiers & Packaging
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. Twenty-four (24) bottles are packed in each shipper. NDC 0065-0411-30 Store at 15°C to 25°C (59°F-77°F). Rx Only Single-use only @2021 Alcon Inc. Alcon Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Manufactured by: Woodstock Sterile Solutions, Inc. Woodstock, IL 60098 *BETADINE is a registered trademark of Purdue Products L.P. STW-AC6024-642R01; 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 1 Fl. Oz. (30 mL) Alcon 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°- 25°C (59°- 77°F). 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: Woodstock Sterile Solutions Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P. Alcon Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0515 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 1 Fl. Oz. (30 mL) Alcon ® a 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°- 25°C (59°- 77°F). ©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, LLC Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P. Alcon ® Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0514 Rx only NDC 0065-0411-30 Betadine * 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. for Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA *BETADINE Reg. TM of Purdue Products L.P. H12639-0515 Rx only NDC 0065-0411-30 Betadine ® 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. for Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA H12639-0514
- 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. Twenty-four (24) bottles are packed in each shipper. NDC 0065-0411-30 Store at 15°C to 25°C (59°F-77°F). Rx Only Single-use only @2021 Alcon Inc. Alcon Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 Manufactured by: Woodstock Sterile Solutions, Inc. Woodstock, IL 60098 *BETADINE is a registered trademark of Purdue Products L.P. STW-AC6024-642R01
- 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 1 Fl. Oz. (30 mL) Alcon 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°- 25°C (59°- 77°F). 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: Woodstock Sterile Solutions Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P. Alcon Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0515 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 1 Fl. Oz. (30 mL) Alcon ® a 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°- 25°C (59°- 77°F). ©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, LLC Woodstock, IL 60098 *BETADINE Reg. TM of Purdue Products L.P. Alcon ® Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 9008803-0514 Rx only NDC 0065-0411-30 Betadine * 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. for Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA *BETADINE Reg. TM of Purdue Products L.P. H12639-0515 Rx only NDC 0065-0411-30 Betadine ® 5% Sterile Ophthalmic Prep Solution (povidone-iodine ophthalmic solution) (0.5% available iodine) 1 fl. oz. (30mL) SINGLE USE ONLY See package insert. Alcon Mfd. for Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA H12639-0514
Overview
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: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.
Indications & 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).
Dosage & 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. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently pour entire contents of bottle into a 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 a 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 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.
Warnings & Precautions
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Contraindications
: Do not use on individuals known to be sensitive to iodine, or other components of this product.
Adverse Reactions
Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.