Label: POVIDONE IODINE PREP- povidone iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 63517-132-01 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 12, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For External Use Only.
Do not use
As a first aid antiseptic
- Do not use in the eyes or apply over large areas of the body
- In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
- Stop use and consult a doctor if the condition persists or gets worse
- Do not use longer than 1 week unless directed by a doctor
For preoperative patient skin preparation
- Do not use in the eyes
- Discontinue use if irritation and redness develop
- If condition persists for more than 72 hours, consult a doctor
- Directions:
- Other information
- Inactive Ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE PREP
povidone iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63517-132-01 500 in 1 CASE 08/25/2016 1 22.2 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/26/2015 Labeler - Cardinal Health (961027315)