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| Product NDC Code | 0065-0411 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 312570, 1149663 |
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| Application Number | NDA018634 | ||||
| Labeler Name | Alcon Laboratories, Inc. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS: Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY: 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/cm2.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS: Do not use on individuals known to be sensitive to iodine, or other components of this product.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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: purified water, citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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: 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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).
Spl product data elements
Usually a list of ingredients in a drug product.Betadine povidone-iodine POVIDONE-IODINE IODINE CITRIC ACID MONOHYDRATE GLYCERIN NONOXYNOL-9 SODIUM CHLORIDE SODIUM HYDROXIDE SODIUM PHOSPHATE, DIBASIC chemical carton label carton Label
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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 a 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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from BETADINE* 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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 a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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 a 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 a pregnant woman or can affect reproductive capacity. BETADINE* 5% Sterile Ophthalmic Prep Solution should only be used on a 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, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API