NDC Code(s) : 65517-0030-1, 65517-0030-3
Packager : Dukal Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PVP-Iodine Swabstick ThreesPovidone-iodine SWAB
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65517-0030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Povidone-iodine(UNII: 85H0HZU99M)
(Iodine - UNII:9679TC07X4) 		Iodine0.9 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin(UNII: PDC6A3C0OX)
Hydroxyethyl Cellulose (2000 MPA.S At 1%)(UNII: S38J6RZN16)
Nonoxynol-10(UNII: K7O76887AP)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Sodium hydroxide(UNII: 55X04QC32I)
Water(UNII: 059QF0KO0R)
C12-20 Alkyl Glucoside(UNII: K67N5Z1RUA)
Potassium iodide(UNII: 1C4QK22F9J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65517-0030-11000 in 1 CASE 31/01/2018
13 in 1 POUCH
1100 mL in 1 APPLICATOR Type 0: Not a Combination Product
2NDC:65517-0030-3500 in 1 CASE 31/01/2018
23 in 1 POUCH
2100 mL in 1 APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/31/2018

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 869-1000

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
SWABSTICKS

1000/Case

1/Pack

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973024897

Principal Display Panel - PVP-I Prep Swabstick 869-1000 Case Label

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 869

NON-STERILE
POVIDONE-IODINE 10%

POVIDONE
IODINE
SWABSTICKS

1
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

D11021701

Principal Display Panel - PVP-I Prep Swabstick 869-1000 Pouch Label

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 867-500

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
SWABSTICKS

500/Case

3/Pack

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 50665973024658

Principal Display Panel - PVP-I Prep Swabstick 867-1000 Case Label

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 867

NON-STERILE
POVIDONE-IODINE 10%

POVIDONE-IODINE
SWABSTICKS

3
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

D02231206 Rev1

Principal Display Panel - PVP-I Prep Swabstick 867-1000 Pouch Label

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 867

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
SWABSTICKS

10 Boxes/Case

25 Packs/Box

3/Pack

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973024651

Principal Display Panel - PVP-I Prep Swabstick 867 Case Label

PRINCIPAL DISPLAY PANEL

DUKAL™
CORPORATION

REF 867

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
SWABSTICKS

25
/box

3/Pouch

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

D02231207 Rev1

Principal Display Panel - PVP-I Prep Swabstick 867 Carton Label