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

3/4 Ounce Povidone Iodine Packet

Povidone-iodine 10%

Antiseptic

Warnings

Do not use

For external use only

Ask a doctor before use if injuries are

Stop use and ask a doctor if

Avoid pooling beneath patient

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

Package Label Display Panel

Povidone Iodine Solution

Package Label Display Panel

ACL10SPSL

ACL10SPSL SINGLE SHOT EPIDURAL
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:55553-433

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

Part 1 of 1

APLICARE POVIDONE-IODINE
povidone-iodine solution

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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
premarket notification	K965017	01/21/2009

Labeler - Clint Pharmaceuticals, Inc. (609197785)

Registrant - 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.		107255002	manufacture