ACL10 SINGLE SHOT EPIDURAL - regional anesthesia kit   
Clint Pharmaceuticals, Inc.

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Drug Facts

APLICARE THREE POVIDONE-IODINE SWABSTICKS
[Aplicare, Inc.]

Three 4-inch saturated swabsticks

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 professional assistance or consult a poison control center immediately.

Povidone Iodine Swabs

Package Label Display Panel

ACL10

ACL10 SINGLE SHOT EPIDURAL 
regional anesthesia kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55553-429
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:55553-429-0210 in 1 CASE
11 in 1 PACKAGE, COMBINATION
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 6.5 mL
Part 1 of 1
APLICARE POVIDONE-IODINE TRIPLES 
povidone-iodine solution
Product Information
Item Code (Source)NDC:52380-3101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE9.8 g  in 96.4 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-3101-56.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK96501712/14/2005
Labeler - Clint Pharmaceuticals, Inc. (609197785)
Registrant - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 5/2012
Document Id: 9d2fc842-530a-42c9-acde-018d690c7dbe
Set id: 9a833471-b06c-4aa6-8d8b-e2f05fb316ab
Version: 1
Effective Time: 20120530
 
Clint Pharmaceuticals, Inc.