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Povidone-Iodine by Medline Industries, Inc.

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-943

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, 10% (equivalent to 1% available iodine)




■ Healthcare antiseptic for preparation of the skin prior to surgery

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


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

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

■ 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.


Clean the affected area

  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

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

Inactive Ingredients

Citric Acid, Deionized Water, Glycerin, Polysorbate 80, Sodium Citrate, Sodium Phosphate Dibasic

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

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

povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-943
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:53329-943-6988 mL in 1 BOTTLE
2NDC:53329-943-1359 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.