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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. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. OTC - WHEN USING
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. OTC - ASK DOCTOR
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. INDICATIONS & USAGE
    11. INACTIVE INGREDIENT

Povidone-iodine Prep Pad Product Label

The following document was submitted to the FDA by the labeler of this product Wuxi Medical Instrument Factory. 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.

Package Label.Principal Display Panel



Item# 83791-817-030      NDC# 42947-611-10     Qty. 1ea

Povidone-Iodine Prep Pad

Antiseptic/Germicide, Medium*For Single Use Only

Saturated with a 10% povidone-iodine solution

equivalent to 1% titratable iodine

For External Use Only

Manufactured by:

Wuxi Medical Instrument Factory

No.86 East street, Zhangjing, Wuxi, Jiangsu 214194 China

Made in China


Otc - Active Ingredient



Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)


Otc - Purpose



Purpose

First Aid

Antiseptic


Otc - When Using



Use

First aid to help prevent infection in minor cuts, scrapes, and burns


Warnings



Warnings

For external use only.


Otc - Do Not Use



Do not * use in the eyes * apply over large areas of the body

* use on individuals who are allergic or sensitive to iodine


Otc - Stop Use



Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week


Otc - Ask Doctor



Ask a doctor

in case of deep or puncture wounds, animal bites, serious burns.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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


Indications & Usage



Directions

Clean the affected area

Apply product on the area 1-3 times daily and discard

May be covered with a sterile bandage when dry


Inactive Ingredient



Inactive ingredients

ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide


* Please review the disclaimer below.