Label: POVIDONE IODINE PREP- povidone-iodine solution
- NDC Code(s): 34645-5501-0
- Packager: Jianerkang Medical Co., Ltd
- 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.
Updated March 29, 2021
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- Drug Facts
- Active ingredient
For external use only.
- use in the eyes
- use on individuals who are allergic or sensitive to iodine
- apply over large areas of the body
- use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop. Consult a doctor in case of
- deep or puncture wounds
- animal bites
- serious burns.
For preparation of the skin prior to surgery
- clean the affected area remove swab by stick
- apply to the operative site prior to surgery. For use as a first aid antiseptic
- clean the affected area
- apply a small amount of this product on the area 1-3 times daily
- may be covered with a sterile bandage
- if bandaged,let dry first.
- Other information
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
POVIDONE IODINE PREP
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34645-5501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-10 (UNII: K7O76887AP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34645-5501-0 10 in 1 CARTON 02/03/2017 1 25 in 1 BOX 1 0.045 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/30/2017 Labeler - Jianerkang Medical Co., Ltd (530968767) Establishment Name Address ID/FEI Business Operations Jianerkang Medical Co., Ltd 530968767 manufacture(34645-5501)