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Aplicare Povidone-Iodine by Aplicare Products, LLC.

Medically reviewed on June 19, 2018

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Aplicare Products, LLC.
NDC Code: 52380-0011

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.

Aplicare ® Povidone-Iodine

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

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

Avoid excessive heat. Store at room temperature.

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

Directions

apply locally as needed

Other information
  • 1% titratable iodine
  • not made with natural rubber latex
  • 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

PRINCIPAL DISPLAY PANEL - 30 mL Solution Packet

NDC 52380-0011-1
NPN 02076144

TEAR HERE
POUR

APLICARE

ONE FLUID OUNCE
POVIDONE-IODINE
SOLUTION

ANTISEPTIC
Non-Sterile Solution

1 Fl. oz. (30 mL)

Reorder No. L-1011

APLICARE POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0011
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 
NONOXYNOL-9 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:52380-0011-130 mL in 1 PACKET
2NDC:52380-0011-322.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2017
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIOperations
Aplicare Products, LLC.081068252manufacture(52380-0011)

 
Aplicare Products, LLC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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