FDA Label for Povidone-iodine
View Indications, Usage & Precautions
Povidone-iodine 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.40000-040 NDC 34645-4000-2 Qty. 1ea
Povidone-Iodine Swab Stick
Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat
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
Antiseptic
Otc - When Using
Uses
Health-care antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.
Warnings
Warnings
For external use only.
Otc - Do Not Use
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 longer than 1 week unless directed by a doctor.
Otc - Stop Use
Discontinue useIf irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.
Otc - Ask Doctor
Consult a doctor in case of* deep or puncture wounds * animal bites * serious burns.
Stop use and consult a doctorif the condition persists or gets worse.
Indications & Usage
DirectionsClean the affected areaApply product on the area 1-3 times daily and discardMay be covered with a sterile bandage when dry
DirectionsFor preparation of the skin prior to surgery* clean the affected area * remove swab by stick* apply to the operative site prior to surgeryFor use as a first aid antiseptic* clean the affected area* apply a small amount of this product on the area 1-3 times daily* may be covered with a sterile bandage* if bandaged, let dry first
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Storage And Handling
Other informationStore at room temperature: 15o - 30o C (59o-86o F)
Inactive Ingredient
Inactive ingredients
aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
* Please review the disclaimer below.