ACL5SPS SINGLE SHOT EPIDURAL  -    
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

ACL5SPS

Established Pharmacological Class
SubstancePharmacological Class
ACL5SPS SINGLE SHOT EPIDURAL Regional Anesthesia Kit

ACL5SPS SINGLE SHOT EPIDURAL 
kit
Product Information
Product TypeItem Code (Source)NHRIC:51688-6265
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NHRIC:51688-6265-210 PACKAGE, COMBINATION ( KIT) in 1 CASEcontains a PACKAGE, COMBINATION
11 KIT ( KIT) in 1 PACKAGE, COMBINATIONThis package is contained within the CASE (51688-6265-2)
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 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52380-0001-322.5 mL in 1 PACKETNone
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 notificationK96501701/21/2011

Labeler - Smiths Medical ASD, Inc. (137835299)
Registrant - Clint Pharmaceticals, Inc. (609197785)
Establishment
NameAddressID/FEIOperations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002manufacture

Revised: 05/2012 Smiths Medical ASD, Inc.