Label: POVIDONE-IODINE solution
- NDC Code(s): 53329-944-04
- Packager: Medline Industries, LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated December 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
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.
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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
- Inactive Ingredients
- Manufacturing Information
- Package Label
-
INGREDIENTS AND APPEARANCE
POVIDONE-IODINE
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-944 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) GLYCERIN (UNII: PDC6A3C0OX) MONOETHANOLAMINE (UNII: 5KV86114PT) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-944-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/04/2016 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
