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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)

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

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.

Directions

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

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:53329-943
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
WATER 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
GLYCERIN 
POLYSORBATE 80 
Packaging
#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)

 
Medline Industries, Inc.

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Medically reviewed on Nov 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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