A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE by Smiths Medical ASD, Inc. / Aplicare, Inc.

A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE by

Drug Labeling and Warnings

A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE 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]

A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE- anesthesia conduction kit   
Smiths Medical ASD, Inc.

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Drug Facts

Povidone-iodine

Antiseptic

Antiseptic skin preparation

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

Avoid excessive heat. Store at room temperature.

Keep out of reach of children

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

Apply locally as needed.

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

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

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

APLICARE

POVIDONE-IODINE SOLUTION

ANTISEPTIC

STERILE Solution

Package Label Display Panel

A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE 
anesthesia conduction kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:51688-9322

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:51688-9322-2	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; Type 0: Not a Combination Product

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	02/07/2006	02/13/2020

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.		081054904	manufacture

Revised: 2/2020

Document Id: 95493055-bff8-4ad2-9643-379a2146e165

55439-4

Set id: 0b627282-0bfe-4726-ab1b-a3f05596f0e1

Version: 3

Effective Time: 20200213