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.

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943 PVP Prep Solution

Active Ingredient

Povidone-Iodine, 10%

(equivalent to 1% available iodine)

Purpose

Antiseptic

Uses

■ Healthcare antiseptic for preparation of the skin prior to surgery

■ First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

■ in the eyes

■ longer than 1 week unless directed by a doctor

■ on individuals who are allergic or sensitive to iodine

■ or apply over large areas of the body

Stop use and ask a doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

Keep out of reach of children.

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

Directions

Clean the affected area

Other Information

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

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, Nonylphenol 9, Purified Water, Sodium Citrate

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: 503911
V1 RK22DEG

Package Label

Label V1 RK22DEG

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-943
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
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-943-6988 mL in 1 BOTTLE; Type 0: Not a Combination Product11/04/2016
2NDC:53329-943-1359 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: efe05a36-f8ba-254f-e053-2995a90a0102
Set id: 42775923-a343-6149-e054-00144ff8d46c
Version: 4
Effective Time: 20221215
 
Medline Industries, LP