AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION- povidone iodine 5 % topical solution solution

Aurodone Povidone Iodine 5 % Opthalmic Solution by

Drug Labeling and Warnings

Aurodone Povidone Iodine 5 % Opthalmic Solution by is a Otc medication manufactured, distributed, or labeled by Aurolab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone Iodine IP 5% w/v.

INACTIVE INGREDIENT

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

USE

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

cause skin infection

QUESTIONS

Call. 1-800-103-7321,

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

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

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

DO NOT USE

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

WARNINGS

For External use only

INDIACATIONS AND USAGE

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

Purpose

Antiseptic

Dose

• 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

INGREDIENTS AND APPEARANCE

AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION 
povidone iodine 5 % topical solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16030-601
Route of Administration	TOPICAL

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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POTASSIUM IODATE (UNII: I139E44NHL)
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16030-601-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/31/2023

Labeler - Aurolab (677319965)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolab		677319965	manufacture(16030-601)