Label: NON-STERILE- povidone-iodine patch
- NDC Code(s): 59050-553-11
- Packager: Changzhou Maokang Medical Products 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 September 12, 2018
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- Drug Facts
- Active ingredient
Stop use and ask a doctor if
- redness, irritation, swelling or pain persists or increases
- infection occurs
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Avoid pooling beneath patient.
- Other information
- Inactive ingredients:
- Package Labeling:
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59050-553 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) NONOXYNOL-10 (UNII: K7O76887AP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM IODIDE (UNII: 1C4QK22F9J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59050-553-11 22.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 06/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/29/2018 Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073) Establishment Name Address ID/FEI Business Operations Changzhou Maokang Medical Products Co., Ltd 421317073 manufacture(59050-553)