NDC Code(s) : 53329-906-69, 53329-906-13
Packager : Medline Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Povidone-IodinePovidone-Iodine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53329-906
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE(UNII: 85H0HZU99M)
(IODINE - UNII:9679TC07X4) 		IODINE1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM NITRITE(UNII: M0KG633D4F)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
NONOXYNOL-9(UNII: 48Q180SH9T)
WATER(UNII: 059QF0KO0R)
CUPRIC SULFATE(UNII: LRX7AJ16DT)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53329-906-6988 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2015
2NDC:53329-906-1359 mL in 1 BOTTLE Type 0: Not a Combination Product07/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/12/2015 12/31/2018

PRINCIPAL DISPLAY PANEL

PVP PREP SOLUTION

TOPICAL ANTISEPTIC

POVIDONE-IODINE 10%

Single use only.

Not made with natural rubber latex.

2 fl oz. (59 mL)

REF 59269

2 oz bottle label

PRINCIPAL DISPLAY PANEL

PVP PREP SOLUTION

TOPICAL ANTISEPTIC

POVIDONE-IODINE 10%

Single use only.

Not made with natural rubber latex.

3 fl oz. (88 mL)

REF 59270

3 oz bottle label