POVIDONE-IODINE- povidone-iodine solution 
Medline Industries, LP

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.

----------

944 PVP Scrub Solution

Active Ingredient

Povidone-Iodine, 7.5%

(equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

Warnings

For external use only.

Do not use

  • in the eyes
  • if you are allergic to iodine or any of the other ingredients in the product.

When using this product

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

Stop use and ask a doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Surgical Hand Scrub:

Patient Pre-operative Skin Preparation:

Other Information

Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, Water

Manufacturing Information

Manufactured for:
Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
Made in Mexico
www.medline.com
1-800-MEDLINE (633-5463)
REF: 500762
V1 RK22DEG

Package Label

Label V1 RK22DEG

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-944
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-944-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/04/2016
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efe0670e-8a15-41f2-e053-2a95a90a3216
Set id: 4275ce04-650f-01f2-e054-00144ff88e88
Version: 5
Effective Time: 20221215
 
Medline Industries, LP