Label: SPLINTER FIRST AID KIT- povidone iodine, kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0498-0120-00, 0498-9002-00 - Packager: Honeywell Safety Products USA, Inc
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 23, 2018
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INGREDIENTS AND APPEARANCE
SPLINTER FIRST AID KIT
povidone iodine, kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-9002 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-9002-00 1 in 1 KIT 12/29/2017 1 1 in 1 POUCH; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 3 POUCH 1 mL Part 1 of 1 NORTH PVP IODINE WIPE
povidone-iodine 10% swabProduct Information Item Code (Source) NDC:0498-0120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0498-0120-00 0.3 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 unapproved drug other 12/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/29/2017 Labeler - Honeywell Safety Products USA, Inc (079287321) Registrant - Honeywell Safety Products USA, Inc (079287321) Establishment Name Address ID/FEI Business Operations Honeywell Safety Products USA, Inc 079287321 pack(0498-9002) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical 532775194 manufacture(0498-0120)