Povidone-iodine
FDA Label NDC 68113-107

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carribbean Medical Brokers D.b.a. Specialty Medical Supplies for the product Povidone-iodine (NDC 68113-107). 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, consult a doctor in case of, stop use and consult a doctor, keep out of reach of children., 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% v/v

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
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic for longer than 1 week unless directed by a doctor.
    • Discontinue use if irritation and redness develop.

Consult A Doctor In Case Of

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Consult A Doctor

If condition persists or gets worse.

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
  • apply a small amount of this product to the area

    • For use as a first aid antispetic

    • clean the affected area
    • apply a small amount of the product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • If bandaged, let dry first.

Other Information:

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

Inactive Ingredients

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

Package Label

Specialty Medical SuppliesPovidone Iodine Prep Pads MediumFor Individual, Professional and Hospital UseSaturated with 10% Povidone Iodine for external use only100 Individual PadsLatex freeTwo ply folded pad10% Povidone Iodine for optimum bacterial actionUse for preparation of the skin prior to an injection;to decrease germs in minor cuts and scrapes.Four layer wrapper provides air-tight seal...prevents leakage and drying out.Manufactured bySpecialty Medical SuppliesCoral Springs, FL 33065954-752-5603www.specialtymedicalsupplies.comMade in ChinaSpecialty Medical SuppliesPovidone Iodine Prep Pads MediumFor Individual, Professional and Hospital UseSaturated with 10% Povidone Iodine for external use only200 Individual PadsLatex freeTwo ply folded pad10% Povidone Iodine for optimum bacterial actionUse for preparation of the skin prior to an injection;to decrease germs in minor cuts and scrapes.Four layer wrapper provides air-tight seal...prevents leakage and drying out.Manufactured bySpecialty Medical SuppliesCoral Springs, FL 33065954-752-5603www.specialtymedicalsupplies.comMade in China

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