Label: POVIDONE-IODINE PAD- povidone-iodine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 42339-002-01, 42339-002-02 - Packager: Shandong Haiyan Medical Manufacture Co., Ltd.
- 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 March 9, 2012
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- Active Ingredient
- Use
- Warnings
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POVIDONE-IODINE PAD
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42339-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 9.43 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE (UNII: SE337SVY37) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42339-002-01 10 in 1 CONTAINER 1 100 in 1 BOX 1 0.6 g in 1 POUCH 2 NDC:42339-002-02 100 in 1 CONTAINER 2 100 in 1 BOX 2 0.6 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 02/18/2012 Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439) Establishment Name Address ID/FEI Business Operations Shandong Haiyan Medical Manufacture Co., Ltd. 421283439 manufacture
