Povidone Iodine Prep Pad
FDA Label NDC 50730-3201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Povidone Iodine Prep Pad (NDC 50730-3201). 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 active ingredient, purpose, uses, warnings, do not use, ask a doctor in case of, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone Iodine 10% w/v (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

  • First Aid Antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Health Care Antiseptic for preparation of the skin prior to surgery

Warnings

For external use only.


Do Not Use

  • in the eyes
  • apply over large areas of the body
  • use on individuals who are allergic or sensitive to iodine
  • use as a first aid antiseptic for longer than 1 week unless directed by a doctor

Ask A Doctor In Case Of

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Ask Doctor/Pharmacist


Otc - When Using


Stop Use And Ask A Doctor

  • if condition persists for more than 72 hours
  • if irritation and redness develop

Otc - Pregnancy Or Breast Feeding


Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the affected area
  • apply a small amount of this product to the area 1-3 times daily and discard
  • may be covered with a sterile bandage when dry

Other


Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients

Citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

Otc - Questions


Package Information

Triad

Cat. No. 10-3201
NDC 50730-3201-1

Povidone Iodine
Prep Pads

Antiseptic / Germicide
  • Helps prevent the risk of infection in minor cuts, scrapes and burns
  • Health-care antiseptic for preparation of the skin prior to surgery
  • For Professional and Hospital Use Only
  • 10% Povidone Iodine, USP
    • Latex Free

    100 Pads

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029
    www.triad-group.net
    1-800-288-1288

    MADE IN USA

    Carton (10 3201c C1109)

    Carton (10 3201c C1109)



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