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Name:Aplicare Povidone-iodine Solution
Manufacturer:Aplicare, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


APLICARE POVIDONE-IODINE SOLUTION  - 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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One Ounce Povidone Iodine Packet

One Ounce 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 SOLUTION 
povidone-iodine solution solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE 9.8 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
SODIUM PHOSPHATE, DIBASIC  
SODIUM HYDROXIDE  
NONOXYNOL-9  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52380-0001-1 30 g in 1 PACKET None
2 NDC:52380-0001-3 22 g in 1 PACKET None
3 NDC:52380-0001-5 1 g in 1 PACKET None
4 NDC:52380-0001-6 2 g in 1 PACKET None
5 NDC:52380-0001-8 2 g in 1 PACKET None
6 NDC:52380-0001-9 7 g in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 03/01/1984

Labeler - Aplicare, Inc. (107255002)
Establishment
Name Address ID/FEI Operations
Aplicare, Inc. 107255002 manufacture

Revised: 12/2009 Aplicare, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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