NDC Code(s) : 29983-0003-1, 29983-0003-4, 29983-0003-6, 29983-0003-7, 29983-0003-8, 29983-0003-9
Packager : IBA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BACSTOP IODINE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29983-0003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IODINE(UNII: 9679TC07X4)
(IODINE - UNII:9679TC07X4)
IODINE5 g in 1 L
Inactive Ingredients
Ingredient Name Strength
NONOXYNOL-30(UNII: JJX07DG188)
NONOXYNOL-9(UNII: 48Q180SH9T)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
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
1NDC:29983-0003-13.78 L in 1 DRUM
2NDC:29983-0003-418.9 L in 1 DRUM
3NDC:29983-0003-656.7 L in 1 DRUM
4NDC:29983-0003-7113.4 L in 1 DRUM
5NDC:29983-0003-8207.9 L in 1 DRUM
6NDC:29983-0003-91039.5 L in 1 DRUM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/23/2010

PRINCIPAL DISPLAY PANEL

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