By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo

TheMediTary.Com

Medical Information, Documents, News - TheMediTary.Com

  • Home
  • News
  • Drugs
  • Drugs A-Z
  • Medical Answers
  • About Us
  • Contact
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo
Search Drugs
  • Drugs
    • Latest Drugs
    • Drugs A-Z
    • Medical Answers
  • News
    • FDA Alerts
    • Medical News
    • Health
    • Consumer Updates
    • Children's Health
  • More TheMediTary.Com
    • About Us
    • Contact
Follow US
Home > Drugs > Ophthalmic anti-infectives > Betadine ophthalmic solution > Betadine Ophthalmic Prescribing Information
Ophthalmic anti-infectives
https://themeditary.com/pro/betadine-ophthalmic-prescribing-information-15355.html

Betadine Ophthalmic Prescribing Information

Drug Detail:Betadine ophthalmic solution (Povidone iodine ophthalmic [ po-vi-done-eye-oh-dine ])

Drug Class: Ophthalmic anti-infectives

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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:

chemical

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: 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.

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 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

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

ADVERSE REACTIONS: Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.

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:

  1. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off.
  2. 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.
  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.

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

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

carton

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

carton

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

Label

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

label
BETADINE
povidone-iodine solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0065-0411
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-0411-301 in 1 CARTON04/01/2000
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01863404/01/2000
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Woodstock Sterile Solutions, Inc.117895702manufacture(0065-0411)

Share this Article
Latest News
Medical News

Shingles vaccine may lower heart disease risk by up to 8 years

May 09, 2025
Obesity, unhealthy lifestyles may cause heart to age by 5–45 years
Aging: As little as 5 minutes of exercise may keep the brain healthy
Prostate cancer: Simple urine test may help with early detection
Cancer treatment side effects: Exercise may reduce pain, fatigue
Alzheimer's: Exercising in middle age may reduce beta-amyloid in brain...
Related Drugs
Fidanacogene Elaparvovec
Cerave Anti-Itch
Centrum Adult
Crovalimab
Cyltezo Prefilled Syringe
Zepbound Pen
Mylanta One
Uretron Ds
Medihoney Wound And Burn Dressing
Lidotrode

Other drugs

Name Drug Class Updated
Fidanacogene Elaparvovec Drugs 03-Oct-2024
Cerave Anti-Itch Drugs 02-Oct-2024
Centrum Adult Drugs 02-Oct-2024
Crovalimab Drugs 02-Oct-2024
Cyltezo Prefilled Syringe Drugs 01-Oct-2024
Zepbound Pen Drugs 30-Sep-2024
Mylanta One Drugs 27-Sep-2024
Uretron Ds Drugs 27-Sep-2024
Medihoney Wound And Burn Dressing Drugs 26-Sep-2024
Lidotrode Drugs 26-Sep-2024
Libervant Drugs 26-Sep-2024
Moderna Covid-19 Drugs 25-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024

Categories

  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health

About US

Welcome to TheMediTary.Com

Our website provides reliable and up-to-date information on various medical topics. We empower individuals to take charge of their health by simplifying complex medical jargon and providing practical tips and advice. We prioritize the privacy and confidentiality of our users and welcome feedback to improve our services.

Website use data of FDA and other sources

DMCA.com Protection Status Truste Protection Status Trust Mark Protection Status
HONcode logo We comply with the HONcode standard for trustworthy health information.
Quick Link
  • About Us
  • Contact Us
  • Editorial Policy
  • Privacy Policy
  • Accessibility Policy
  • Terms & Conditions
  • Disclaimer
  • DMCA
  • Do Not Sell My Personal Information
  • Sitemap
  • Care Notes
  • Health Guide
  • Professional
Drugs
  • New Drugs
  • Medical Answers
  • Drugs A-Z
  • Drug Classes
  • Drug Dosage
  • Pill Identifier
  • Consumer Infor
  • Side Effects
  • Inactive Ingredients
  • Pregnancy Warnings
  • Patient Tips
  • Treatments
News
  • Latest News
  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health
Find US
  • Medium
  • Google Site
  • Blogspot
  • API
  • Reddit
  • Tumblr
  • Scoop.it
  • Substack
  • Wordpress
  • Wix
  • Behance

© 2025 TheMediTary.Com All rights reserved. Operated by