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

----------

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 TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-1236
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-1236-210 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 22.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE  
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0001-322.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceHIO12/14/2005
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

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.