PVP-IODINE SWABSTICK THREES- povidone-iodine swab
Dukal Corporation

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.

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Drug Facts

Active Ingredient:

Povidone-Iodine USP 10%

Purpose:

Antiseptic

Use:

For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

Warnings:

For external use only.

Do not apply to persons allergic to iodine. Do not use in the eyes.

Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Keep out of reach of children
If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions:

Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

Other Information:

1% titratable iodine, for hospital or professional use only.

Store at ambient temperatures.

Inactive Ingredients:

Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

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

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 - PVP-I Prep Swabstick 869-1000 Pouch Label

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 - PVP-I Prep Swabstick 867-1000 Case Label

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 - PVP-I Prep Swabstick 867-1000 Pouch Label

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 - PVP-I Prep Swabstick 867 Case Label

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 - PVP-I Prep Swabstick 867 Carton Label

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

PVP-IODINE SWABSTICK THREES
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65517-0030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.9 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65517-0030-1	1000 in 1 CASE	01/31/2018	01/31/2018
1		3 in 1 POUCH
1		100 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:65517-0030-3	500 in 1 CASE	01/31/2018	01/31/2018
2		3 in 1 POUCH
2		100 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/31/2018	01/31/2018

Labeler - Dukal Corporation (791014871)

Name	Address	ID/FEI	Business Operations
Establishment
Changzhou Maokang Medical Products Co.,Ltd		421317073	manufacture(65517-0030)

Revised: 8/2018

Document Id: 73a6351c-5a7b-abbf-e053-2991aa0a5382

Set id: 4ff16f8b-77fd-45b0-a06f-601478178e1f

Version: 4

Effective Time: 20180817

Dukal Corporation