Aplicare Povidone-iodine Paint
FDA Label NDC 52380-4011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aplicare, Inc. for the product Aplicare Povidone-iodine Paint (NDC 52380-4011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, do not use, ask a doctor before use if injuries are, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

Active Ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

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

Otc - Keep Out Of Reach Of Children

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

Storage And Handling

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

Otc - Questions

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

Principal Display Panel (2 Sponge Sticks Packet)

Principal Display Panel (2 Sponge Sticks Packet)

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