Aplicare Povidone-iodine Solution
FDA Label NDC 52380-0011

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 Products, Llc for the product Aplicare Povidone-iodine (NDC 52380-0011). 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, storage and handling, 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 patient

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 or puncture wounds
  • serious burns

Stop Use And Ask A Doctor If

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

Storage And Handling

Avoid excessive heat. Store at room temperature.

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.

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

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 - 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

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