A3930-18 CONTINUOUS EPIDURAL 18G TUOHY - regional anesthesia kit   
Smiths Medical ASD, 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

  • 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 professional assistance or consult a poison control center immediately.

Povidone Iodine Swabs

Package Label Display Panel

A3930-18

A3930-18 CONTINUOUS EPIDURAL 18G TUOHY 
regional anesthesia kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-6250
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:51688-6250-210 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE9.8 g  in 96.4 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
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 notificationK96501711/30/2011
Labeler - Smiths Medical ASD, Inc. (137835299)
Establishment
NameAddressID/FEIBusiness Operations
Smiths Medical ASD, Inc.137835299relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 4/2012
 
Smiths Medical ASD, Inc.