Povidone-iodine Prep Swabstick
FDA Label NDC 50730-4101

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 Swabstick (NDC 50730-4101). 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, 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% w/v (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 the risk of infection in minor cuts, scrapes and burns

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

For preparation of the skin prior to surgery
  • clean the affected area
  • remove swab by stick
  • 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 room temperature 15° - 30° C (59° - 86° F)

Inactive Ingredients

Citric acid, glycerin, Makon 8, purified water, sodium hydroxide

Otc - Questions


Pouch Information

TRIAD Cat. No. 10-4101 NDC 50730-4101-1 10% Povidone Iodine, USP POVIDONE IODINE SWABSTICKS (1's) Antiseptic / Germicide For Hospital and Professional Use Only Triad Disposables, Inc. Brookfield, WI 53045 USA Contents:1 Swabstick

Carton Information

TRIADCat. No. 10-4101NDC 50730-4101-110% Povidone Iodine, USPPOVIDONE IODINESWABSTICKS (1's)Antiseptic / GermicideFor Hospital and Professional Use OnlyTriad Disposables, Inc.Brookfield, WI 53045 USAContents:50 Pouches1 Swabstick per Pouch

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