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Povidone-Iodine by Medline Industries, Inc.

Medically reviewed on April 6, 2017

Dosage form: solution
Ingredients: POVIDONE-IODINE 0.75g in 100mL
Labeler: Medline Industries, Inc.
NDC Code: 53329-938

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 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

Protect from freezing. Avoid excessive heat.

Inactive ingredients

Citric Acid, Cocamide DEA, Disodium Phosphate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water


Principal Display Panel

NDC 53329-938-23

PVP Scrub Solution

Antiseptic

Povidone-Iodine 7.5%

Sudsing Skin Cleanser

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-938
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE0.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
COCO DIETHANOLAMIDE 
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53329-938-06473 mL in 1 BOTTLE
2NDC:53329-938-08237 mL in 1 BOTTLE
3NDC:53329-938-23946 mL in 1 BOTTLE
4NDC:53329-938-253785 mL in 1 BOTTLE
5NDC:53329-938-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2007
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIOperations
Medline Industries, Inc.079800021manufacture(53329-938)

 
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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