A1052-22 AMNIOCENTESIS 22G QUINCKE- sampler, amniotic fluid (amniocentesis tray)   
Smiths Medical ASD, Inc.

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

3/4 Ounce Povidone Iodine Packet

Active Ingredient
Povidone-iodine
Purpose
Antiseptic
Use
Antispetic 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 and ask a doctor if
-redness, irritation, swelling or pain persists or increases
-infection occurs
Keep out of reach of children
In case of accidental ingestion, seek professional help or consult a poison control center immediately.
Directions
Apply locally as needed.
Inactive Ingredients
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Questions or comments?
1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

Povidone Iodine Solution

Package Label Display Panel

A1052-22

A1052-22 AMNIOCENTESIS 22G QUINCKE 
sampler, amniotic fluid (amniocentesis tray) kit
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-1236
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NHRIC:51688-1236-2 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) 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
exempt device HIO 12/14/2005
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. 107255002 manufacture

Revised: 8/2014
Document Id: bee8c188-819f-469b-8994-02707088471a
Set id: d9f0d3ba-1785-4613-9fc3-359d917b1ada
Version: 2
Effective Time: 20140811
 
Smiths Medical ASD, Inc.