Country: United States
Language: English
Source: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Rebel Distributors Corp
POVIDONE-IODINE
IODINE 5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
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. 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.
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
New Drug Application
BETADINE- POVIDONE-IODINE SOLUTION REBEL DISTRIBUTORS CORP ---------- BETADINE® 5% STERILE OPHTHALMIC PREP SOLUTION (POVIDONE-IODINE OPHTHALMIC SOLUTION) (0.5% AVAILABLE IODINE) DESCRIPTION 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. CLINICAL PHARMACOLOGY A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log reduction of 3.05 log units in total aerobes at 10 minutes following prepping the skin with BETADINE® 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log reduction by the iodine complex compared with the control solution of 1.47 log units at 10 minutes and 1.79 log units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms per square cm. 10 10 10 10 10 10 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. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT O Read the complete document