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


Drug Facts

APLICARE POVIDONE-IODINE SCRUB  - 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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Drug Facts

Povidone-iodine Scrub Swabstick Packet

Povidone-Iodine Scrub Swabs, Triples


Povidone-iodine

Antiseptic

Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs
  • injuries are deep or puncture wounds or serious burns

Do not use if allergic to iodine

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Questions or comments?

            1 800 760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)


APLICARE POVIDONE-IODINE SCRUB 
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0025
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE 8.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC  
ANHYDROUS CITRIC ACID  
SODIUM HYDROXIDE  
NONOXYNOL-9  
AMMONIUM NONOXYNOL-4 SULFATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52380-0025-6 2 g in 1 PACKET None
2 NDC:52380-0025-9 8 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 01/01/1984

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

Revised: 01/2010 Aplicare, Inc.



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


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