TUN-L-XL 191-2540- catheter, conduction, anesthetic   
Epimed International

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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

Wiley Spinal

TUN-L-XL  191-2540
catheter, conduction, anesthetic kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:60816-2540
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:60816-2540-11 in 1 PACKAGE
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-iodine (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
122.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK95458410/08/1996
Labeler - Epimed International (799751953)
Establishment
NameAddressID/FEIBusiness Operations
Epimed International799751953relabel, manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 9/2013
Document Id: b68936d9-d09b-4790-b79b-588332731ac9
Set id: a6e0cadc-0f48-4d1d-9a4c-f4c91c1171a1
Version: 1
Effective Time: 20130930
 
Epimed International