WILEY SPINAL 199-2340- kit

Wiley Spinal by

Drug Labeling and Warnings

Wiley Spinal by is a Other medication manufactured, distributed, or labeled by Epimed International, 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

INGREDIENTS AND APPEARANCE

WILEY SPINAL  199-2340
needle, conduction, anesthetic (w/wo introducer) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:60816-2340

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:60816-2340-1	1 in 1 PACKAGE

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		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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K043467	10/08/1996

Labeler - Epimed International (799751953)

Establishment
Name	Address	ID/FEI	Business Operations
Epimed International		799751953	relabel, manufacture

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