FDA Label for Povidone-iodine Prep Pad
View Indications, Usage & Precautions
Povidone-iodine Prep Pad Product Label
The following document was submitted to the FDA by the labeler of this product Jiangsu Province Jianerkang Medical Dressing Co. ,ltd.. 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
Cat.40000-020 NDC 34645-4002-1 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
Distributed by:
Cardinal Health
Dublin, OH 43017 USA
Made in China
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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 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.