Aplicare Povidone-Iodine Solution

Dosage form: solution
Ingredients: POVIDONE-IODINE 9.8g in 100g
Labeler: Aplicare, Inc.
NDC Code: 52380-0001

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.

One Ounce Povidone Iodine 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0001
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 Description
1NDC:52380-0001-130 g in 1 PACKET
2NDC:52380-0001-322 g in 1 PACKET
3NDC:52380-0001-51 g in 1 PACKET
4NDC:52380-0001-62 g in 1 PACKET
5NDC:52380-0001-82 g in 1 PACKET
6NDC:52380-0001-97 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33303/01/1984
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002manufacture

Revised: 12/2009
 
Aplicare, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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