Betadine

Povidone-iodine

Alcon Laboratories, Inc.
Human Prescription Drug
NDC 0065-0411

Betadine also known as Povidone-iodine is a human prescription drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Betadine is 0065-0411. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Betadine drug includes Povidone-iodine - 5 mg/mL . The currest status of Betadine drug is Active.

Drug Information:

Drug NDC:	0065-0411
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Betadine
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Povidone-iodine
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Alcon Laboratories, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	POVIDONE-IODINE - 5 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 Apr, 2000
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	27 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA018634
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Alcon Laboratories, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	312570 1149663
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175486 M0011640
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	85H0HZU99M
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Antiseptic [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Iodine [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0065-0411-30	1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE	01 Apr, 2000	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Betadine

Povidone-iodine

Solution
Alcon Laboratories, Inc.
NDC: 0065-0411

Product Elements:

Betadine povidone-iodine povidone-iodine iodine citric acid monohydrate glycerin nonoxynol-9 sodium chloride sodium hydroxide sodium phosphate, dibasic chemical carton label carton label

Indications and Usage:

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).

Warnings:

Warnings: for external use only. not for intraocular injection or irrigation.

General 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.

Dosage and Administration:

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 Read more...

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.

Contraindications:

Contraindications: do not use on individuals known to be sensitive to iodine, or other components of this product.

Adverse Reactions:

Adverse reactions: local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.

Use in Pregnancy:

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.

Pediatric Use:

Pediatric use: safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Description:

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.

Clinical Pharmacology:

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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.

How Supplied:

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 15Â°c to 25Â°c (59Â°f-77Â°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

Package Label Principal Display Panel:

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: 15Â°- 25Â°c (59Â°- 77Â°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 Â® 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: 15Â°- 25Â°c (59Â°- 77Â°f). Â©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 Â® 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 Â® 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

Comments/ Reviews:

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