Aplicare Povidone-iodine Perineal Wash
FDA Label NDC 52380-1880

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 Perineal Wash (NDC 52380-1880). 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 otc - active ingredient, otc - purpose, otc - ask doctor, otc - do not use, warnings, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Povidone-iodine

Otc - Purpose

Antiseptic

Otc - Ask Doctor

Stop use and ask a doctor if

  • infection occurs
  • redness, irritation, swelling or pain persists or increases
    • Ask a doctor before use if injuries are
    • deep puncture wounds
    • serious burns

Otc - Do Not Use

Do not use if allergic to iodine.

Do not use in eyes.

Warnings

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

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.

Package Label.Principal Display Panel

Bottle Label

Perineal Wash Label (82230lbl)

Perineal Wash Label (82230lbl)

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