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Povidone-Iodine by Medline Industries, Inc.

Dosage form: solution
Ingredients: POVIDONE-IODINE 7.5mg in 1mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-944

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.

Drug Facts

Active Ingredient

Povidone-Iodine, 7.5% (equivalent to 0.75% available iodine)

Purpose

Antiseptic

Uses

■ For preparation of the skin prior to surgery

■ helps to reduce bacteria that potentially can cause skin infection

■ significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

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: ■ Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. ■Wet hands and forearms ■ Apply 5 milliliters (teaspoonful) or palmful to hands and forearms ■ Scrub thoroughly for about 5 minutes paying particular attention to the nails, cuticles, and interdigital spaces ■ Use a sterile scrub brush, if desired ■ Rinse and repeat scrub

Patient Pre-operative Skin Preparation: ■ Prior to surgery, wet skin with water ■ Apply scrub to the operative site ■ scrub thoroughly for about 5 minutes ■ Rinse using sterile gauze or towel, or remove with 70 percent alcohol ■ follow with application of Medline Prep Solution and allow to dry

Other Information

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

Inactive Ingredients

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

www.medline.com

Manufactured for: Medline Industries Inc., Northfield, IL 60093 USA

Made in Mexico To Order Call: 1-800-MEDLINE RK16DEG

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-944
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
GLYCERIN 
MONOETHANOLAMINE 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
Packaging
#Item CodePackage Description
1NDC:53329-944-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/04/2016
Labeler - Medline Industries, Inc. (025460908)

Revised: 11/2016
 
Medline Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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