FDA Label for Povidone Iodine Scrub
View Indications, Usage & Precautions
Povidone Iodine Scrub 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 Iodine USP, 7.5% W/V (equivalent to 0.75% titratable iodine)
Purpose
Antiseptic
Indications & Usage
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
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 larger areas of the body
use as a first aid antiseptic longer than 1 week unless 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
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
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 products 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: 15o - 30oC (59o-86oF)
Citric Acid, Purified Water, Sodium Hydroxide, Nonoxynol-10, Glycerin
citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin
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