Label: BETADINE- povidone-iodine solution
Contains inactivated NDC Code(s)
NDC Code(s): 42254-006-30
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0065-0411
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 25, 2011
If you are a consumer or patient please visit this version.
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.
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.
- INDICATIONS AND USAGE
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.
- Pediatric Use
- Geriatric Use
- ADVERSE REACTIONS
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.
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).
Single use only
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Catalent Pharma Solutions, LLC
Woodstock, IL 60098
Rebel Distributors Corp
Thousand Oaks, CA 91320
BETADINE® is a registered trademark of The Purdue Frederick Company.
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-006(NDC:0065-0411) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42254-006-30 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 - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK