ACL4SP SINGLE SHOT EPIDURAL- kit

ACL4SP SINGLE SHOT EPIDURAL by

Drug Labeling and Warnings

ACL4SP 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

Povidone-iodine

PURPOSE

Antiseptic

Antiseptic skin preparation

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

Stop use and ask a doctor if

-redness, irritation, swelling or pain persists or increases

-infection occurs

Avoid pooling beneath patient

Avoid excessive heat. Store at room temperature.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

INSTRUCTIONS FOR USE

Apply locally as needed.

OTHER SAFETY INFORMATION

1% titratable iodine latex free for hospital or professional use only

INACTIVE INGREDIENT

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

QUESTIONS

1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

PRINCIPAL DISPLAY PANEL

Package Label Display Panel

INGREDIENTS AND APPEARANCE

ACL4SP SINGLE SHOT EPIDURAL 
regional anesthesia kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:55553-445

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:55553-445-02	30 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	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	manufacture

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