APLICARE POVIDONE-IODINE SWABSTICK - povidone-iodine solution 
Aplicare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Povidone Iodine Swabstick, Single

Single Swab 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.


APLICARE POVIDONE-IODINE SWABSTICK 
povidone-iodine swabstick solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52380-1101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE9.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1101-42 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/01/1998
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.107255002manufacture

Revised: 12/2009
Document Id: 926b5fca-a4f7-4269-a0bf-18a884ab8dba
Set id: 0b75eb9f-3f47-4486-a621-8de94f5ac28b
Version: 1
Effective Time: 20091229
 
Aplicare, Inc.