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Aplicare Povidone-Iodine Paint

Medically reviewed on Jun 1, 2017

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Aplicare, Inc.
NDC Code: 52380-4011

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 Paint

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

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

For external use only

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

Avoid pooling beneath the 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
  • for single use only
  • 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 - 2 Sponge Sticks Packet

NDC 52380-4011-2

APLICARE

◀ Tear Here   Hold Upright   Tear Here ▶

TWO POVIDONE-IODINE PAINT
SPONGE STICKS

ANTISEPTIC
Non-Sterile Solution

Two 8-inch Sponge Sticks Saturated with
Povidone-Iodine USP, 1% Available Iodine

Reorder No. F-2011

APLICARE POVIDONE-IODINE PAINT 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4011
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:52380-4011-22 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2017
Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.107255002manufacture(52380-4011)

 
Aplicare, Inc.

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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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