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Aplicare Povidone-Iodine Paint

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Aplicare, Inc.
NDC Code: 52380-0101

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.

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 wounds
  • 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. Prolonged exposure to wet solution may cause skin irritation.

Avoid excessive heat. Store at room temperature.

Directions use sponge sticks to prep desired area

Other information

• 1% titratable iodine

• latex free

• for hospital or professional use only

Inactive Ingredients

• citric acid

• disodium phosphate

• nonoxynol-9

• sodium hydroxide

• water

For questions, comments, or to report serious side effects:

800-760-3236

Monday-Friday

8:30 a.m.-5:00 p.m. EST

APLICARE

POVIDONE-IODINE PAINT

SPONGE STICKS

ANTISEPTIC

STERILE Solution

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

Antiseptic skin preparation

APLICARE POVIDONE-IODINE PAINT 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM HYDROXIDE 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:52380-0101-52 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/1992
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002manufacture(52380-0101)

Revised: 03/2015
 
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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