Your browser does not support JavaScript! A3382-18 S.A.S. SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]
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A3382-18 S.A.S. SINGLE SHOT EPIDURAL () kit
[Smiths Medical ASD, Inc.]


Category DEA Schedule Marketing Status
MEDICAL DEVICE Premarket Notification
Drug Label Sections

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

3/4 Ounce Povidone Iodine Packet

Povidone-iodine 10%

Antiseptic

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

            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

A3382-18

A3382-18 S.A.S. SINGLE SHOT EPIDURAL 
regional anesthesia kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-9844
Packaging
#Item CodePackage Description
1NHRIC:51688-9844-210 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) POVIDONE-IODINE0.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
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
premarket notificationK96501702/06/2006
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 10/2012
Document Id: 28246674-6ca6-4b49-8951-abe66ecd9f79
Set id: 5e1d6935-51c9-4d70-a140-68446f31f6ce
Version: 1
Effective Time: 20121008
 
Smiths Medical ASD, Inc.

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