FDA Label for Povidone Iodine Prep
View Indications, Usage & Precautions
Povidone Iodine Prep Product Label
The following document was submitted to the FDA by the labeler of this product Jianerkang Medical 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.
Active Ingredient
Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)
Purpose
Antiseptic
Use
- 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
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 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 the 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 remove swab by stick
- apply to the operative site prior to surgery. For 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.
Other Information
store at room temperature: 15°－30°C(59°-86°F)
- Avoid excessive heat
Inactive Ingredients
citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin
Package Labeling:
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