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  5. Label Information: Povidone-iodine Prep Pad

FDA Label for Povidone-iodine Prep Pad

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT
    6. CONSULT A DOCTOR IN CASE OF
    7. STOP USE AND CONSULT A DOCTOR
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS:
    10. OTHER INFORMATION:
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL

Povidone-iodine Prep Pad Product Label

The following document was submitted to the FDA by the labeler of this product Carribbean Medical Brokers D.b.a. Specialty Medical Supplies. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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