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

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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

A3383-22

A3383-22 S.A.S. NERVE BLOCK 22G QUINCKE 
regional anesthesia 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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 0.10 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 02/07/2006
Labeler - 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

Revised: 10/2012
Document Id: 3507461d-6443-42ad-b60e-469084c80bfd
Set id: 0b627282-0bfe-4726-ab1b-a3f05596f0e1
Version: 1
Effective Time: 20121008
 
Smiths Medical ASD, Inc.