Label: BETADINE- povidone-iodine solution
- NDC Code(s): 0065-0411-30
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
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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.Close
- 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 per square cm.Close
- 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).Close
Do not use on individuals known to be sensitive to iodine, or other components of this product.Close
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.Close
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.
Category C: 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.
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
Safety and effectiveness in pediatric patients have not been established.Close
- Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.Close
- ADVERSE REACTIONS
Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.Close
- 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
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.Close
- 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 (NDC #0065 0411 30). Twenty-four (24) bottles are packed in each shipper.
Store at 15-25°C (59-77°F).
Single use only
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Catalent Pharma Solutions, LLC
Woodstock, IL 60098
BETADINE® is a registered trademark of The Purdue Frederick Company.
- Principal Display Panel
NDC 0065 0411 30
Sterile Ophthalmic Prep Solution
For Pre-Operative Prep and
Irrigation of the Ocular and
Flush eye thoroughly with
sterile saline solution after
1 Fl. Oz. (30 mL)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0411 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (IODINE) IODINE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE GLYCERIN NONOXYNOL-9 SODIUM CHLORIDE SODIUM HYDROXIDE SODIUM PHOSPHATE, DIBASIC Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0411-30 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018634 04/01/2000 Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Catalent Pharma Solutions, LLC 043911403 MANUFACTURE