Aurodone Povidone Iodine 5 % Opthalmic Solution

Manufacturer
Aurolab
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:01

Label at a glance#

ProductAurodone Povidone Iodine 5 % Opthalmic Solution
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Povidone Iodine IP 5% w/v.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

  1. Citric acid
  2. Disodium hydrogen O- phosphate, Potassium iodate
  3. Glycerin
  4. Purified water

USE

INDICATIONS & USAGE SECTION

  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can

cause skin infection

QUESTIONS

OTC - QUESTIONS SECTION

Call. 1-800-103-7321,

E-mail : info@aurolab.com
Web : www.aurolab.com

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

STOP USE

OTC - STOP USE SECTION

Irritation, sensitization, or allergic reaction
occurs and lasts for 72 hours. These may
be signs of a serious condition.

DO NOT USE

OTC - DO NOT USE SECTION

  1. If you are allergic to povidone-iodine or
    any other ingredients in this preparation
    In the eyes

WARNINGS

WARNINGS SECTION

For External use only

INDIACATIONS AND USAGE

INDICATIONS & USAGE SECTION

Prolonged exposure to wet solution may
cause irritation or, rarely, severe skin
reactions
In pre-operative prepping, avoid “pooling”
beneath the patient

Purpose

OTC - PURPOSE SECTION

Antiseptic

Dose

DOSAGE & ADMINISTRATION SECTION

  • Clean the area and apply product to the operative site prior to surgery.
  • The solution can be used to irrigate the cornea and conjunctiva with a sterile bulb syringe prior to surgery.
  • After the solution has been left in contact for two minutes flush the residual prep solution using a sterile saline solution.

PACKAGE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PovidonePovidone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252965povidone-iodine 5 % Topical SolutionPSN2
252965povidone-iodine 50 MG/ML Topical SolutionSCD2
252965povidone-iodine 5 % (titratable iodine 0.5 % ) Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16030-601-05Aurodone Povidone Iodine 5 % Opthalmic Solution5 mL in 1 BOTTLESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16030-601AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION (POVIDONE IODINE 5 % TOPICAL SOLUTION) SOLUTION [AUROLAB]2Current NDC, 1 package rows20250108_f3444446-1dad-79ff-e053-2a95a90af411.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16030-60116030-601-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aurodone Povidone Iodine 5 % Opthalmic SolutionPOVIDONE IODINE 5 % TOPICAL SOLUTIONAurolabf3444446-1dad-79ff-e053-2a95a90af4112025-01-06WarningsExact identifier
ndc (package): 16030-601-05
ndc (product): 16030-601
ndc11 (package): 16030060105
spl id: 2b059a40-6782-b690-e063-6394a90a06a1
spl set id: f3444446-1dad-79ff-e053-2a95a90af411

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.