A4045-18 SINGLE SHOT EPIDURAL 18G TUOHY- kit

A4045-18 SINGLE SHOT EPIDURAL 18G TUOHY by

Drug Labeling and Warnings

A4045-18 SINGLE SHOT EPIDURAL 18G TUOHY by is a Other medication manufactured, distributed, or labeled by Smiths Medical ASD, Inc., Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]

3/4 Ounce Povidone Iodine Packet

WARNINGS

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 professionalassistance or consult a poison control center immediately.

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

A4045-18 SINGLE SHOT EPIDURAL 18G TUOHY 
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-6388

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-6388-2	10 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	22.5 mL

Part 1 of 1

APLICARE POVIDONE-IODINE  
povidone-iodine solution

Product Information
Item Code (Source)	NDC: 52380-0001
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-0001-3	22.5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/1984

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K965017	01/03/2013

Labeler - Smiths Medical ASD, Inc. (137835299)

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

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		107255002	manufacture