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
Updated October 23, 2023
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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 Drug M003 01/30/2017 Labeler - Jianerkang Medical Co., Ltd (530968767) Establishment Name Address ID/FEI Business Operations Jianerkang Medical Co., Ltd 530968767 manufacture(34645-5501)