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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

PACKAGE CARTON

Povidone

AURODONE POVIDONE IODINE 5 % OPTHALMIC SOLUTION 
povidone iodine 5 % topical solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
POTASSIUM IODATE (UNII: I139E44NHL)  
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16030-601-055 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/31/2023
Labeler - Aurolab (677319965)
Establishment
NameAddressID/FEIBusiness Operations
Aurolab677319965manufacture(16030-601)

Revised: 1/2023
Document Id: f3444446-1dae-79ff-e053-2a95a90af411
Set id: f3444446-1dad-79ff-e053-2a95a90af411
Version: 1
Effective Time: 20230126
 
Aurolab