POVIDONE-IODINE- povidone-iodine solution 
James Alexander Corporation

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POVIDONE IODINE TOPICAL SOLUTION USP

Drug Facts

Active Ingredients (each swab)

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose

Topical Antiseptic

Uses

To treat minor skin cuts and abrasions.

Warnings

For external use only.

Ask a doctor before use if you have • deep or puncture wounds • serious burns

Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases
                                                • infection occurs.

Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Other Information

 Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Questions?

Call 1-908-362-9266 Monday through Friday, 9:00am - 5:00pm e.s.t.

DISPENSING SOLUTIONS®

JAMES ALEXANDER CORPORATION
Blairstown, NJ• (908) 362-9266
Product information and MSDS available on-line at:
www.james-alexander.com

Void of Aqueous

Packaging

image description

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-7777
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46414-7777-310 in 1 CONTAINER02/14/1976
10.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:46414-7777-2100 in 1 CONTAINER02/14/1976
20.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00302/14/1976
Labeler - James Alexander Corporation (040756421)
Registrant - James Alexander Corporation (040756421)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander Corporation040756421manufacture(46414-7777)

Revised: 11/2023
Document Id: e3f403b7-abfb-49b1-86c0-ac3a4156c6f6
Set id: 181a6363-2249-45f0-a28b-79f2c5ffad59
Version: 7
Effective Time: 20231121
 
James Alexander Corporation