A4097 SPINAL by Smiths Medical ASD, Inc. / Aplicare, Inc. A4097 SPINAL- kit

A4097 SPINAL by

Drug Labeling and Warnings

A4097 SPINAL 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]

Drug Facts

APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]
3/4 Ounce Povidone Iodine Packet
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.

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

A4097 SPINAL 
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-6429

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-6429-2	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	10/24/2013

Labeler - Smiths Medical ASD, Inc. (137835299)

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

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