Povidone Iodine Plus
FDA Label NDC 50730-8214

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 Plus (NDC 50730-8214). 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 USP 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

  • Health care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.


Do Not Use

  • in the eyes
  • on individuals who are allergic or sensitive to iodine
  • as a first aid antiseptic 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

  • 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

For preparation of the skin prior to surgery
  • apply to the operative site prior to surgery
    • As a first aid antiseptic
    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first

Other


Other Information

Store at 15° - 30° C (59° - 86° F)

Inactive Ingredients

Citric acid, glycerin, hydroxyethylcellulose, sodium hydroxide, water

Otc - Questions


Package Information

Cat. No. 11-LP14
NDC 50730-8214-8

TRIAD Plus

POVIDONE IODINE
PREP GEL

Povidone Iodine, USP
10% Topical Gel

  • ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
  • For Hospital and Professional use.
    • 4 Fluid Ounces (118 ml)

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029    Made In USA
    www.triad-group.net

    Label (11 Lp14l B0210)

    Label (11 Lp14l B0210)





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