6800 PORTEX CENTRAL LINE DRESSING- regional anesthesia kit
Smiths Medical ASD, Inc.

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Drug Facts

APLICARE THREE POVIDONE-IODINE SWABSTICKS
[Aplicare, Inc.]

Three 4-inch saturated swabsticks

Povidone-iodine 10%

Antiseptic

Warnings

Do not use

if allergic to iodine
in the eyes

For external use only

Ask a doctor before use if injuries are

deep or puncture wounds
serious burns

Stop use and ask a doctor if

redness, irritation, swelling or pain persists or increases
infection occurs

Avoid pooling beneath patient

Keep out of reach of children.In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Povidone Iodine Swabs

Drug Facts

Ointment Drug Facts

Package Label Display Panel

Ointment Packet

Package Label Display Panel

6800

6800 PORTEX CENTRAL LINE DRESSING
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-5133

#	Item Code	Package Description
Packaging
1	NHRIC:51688-5133-1	20 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 PACKET	6.5 mL
Part 2	1 PACKET	1 g

Part 1 of 2

APLICARE POVIDONE-IODINE TRIPLES
povidone-iodine solution

Product Information
Item Code (Source)	NDC:52380-3101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-3101-5	6.5 mL in 1 PACKET; 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	part333A	03/01/1998

Part 2 of 2

APLICARE POVIDONE-IODINE
povidone-iodine ointment

Product Information
Item Code (Source)	NDC:52380-0026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)	Iodine	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52380-0026-1	1 g in 1 PACKET; 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	part333A	07/01/1984

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
premarket notification	K965017	12/14/2005	01/03/2020

Labeler - Smiths Medical ASD, Inc. (137835299)

Name	Address	ID/FEI	Business Operations
Establishment
Smiths Medical ASD, Inc.		137835299	relabel, manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aplicare, Inc.		081054904	manufacture

Revised: 1/2020

Document Id: 45bab771-624c-41ed-be7f-26bc37727ec7

Set id: c4c4b8c4-6102-4001-938b-b27af190117c

Version: 2

Effective Time: 20200103

Smiths Medical ASD, Inc.