ACL1 SINGLE SHOT EPIDURAL- kit

ACL1 SINGLE SHOT EPIDURAL by

Drug Labeling and Warnings

ACL1 SINGLE SHOT EPIDURAL by is a Other medication manufactured, distributed, or labeled by Clint Pharmaceuticals, Inc., Smiths Medical ASD, Inc., Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

ACL1 SINGLE SHOT EPIDURAL 
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:55553-428

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:55553-428-02	10 in 1 CASE
1		1 in 1 PACKAGE, COMBINATION

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

Part 1 of 1

APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	POVIDONE-IODINE	9.8 g  in 96.4 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-3101-5	6.5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/1998

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

Labeler - Clint Pharmaceuticals, Inc. (609197785)

Registrant - 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