Active Ingredient
Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)
Povidone Iodine Scrub Swab
FDA Label NDC 34645-4050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jianerkang Medical Co., Ltd for the product Povidone Iodine Scrub (NDC 34645-4050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Inactive Ingredients
citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin
Package Label.Principal Display Panel
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Pouch Label (Pouch)
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