Povidone Iodine Prep Pad Sterile Cloth
FDA Label NDC 34645-0022
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 Prep Pad Sterile (NDC 34645-0022). 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 drug facts, active ingredient, purpose, use, warnings, do not, stop use and consult a doctor, ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Povidone Iodine USP, 10% w/w (equivalent to 1% titratable iodine)
Purpose
Antiseptic
Use
First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings
For external use only.
Do Not
- use in the eyes
- apply over large over large areas of the body
- use on individuals who are allergic or sensitive to iodine.
Stop Use And Consult A Doctor
- if the condition persists or gets worse
- for use longer than 1 week.
Ask A Doctor
in case of deep or puncture wounds, animal bites, serious burns.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the affected area
- Apply the product on the area and discard
- May be covered with a sterile bandage when dry.
Other Information
- Avoid excessive heat.
- Store at room temperature.
Inactive Ingredients
Citric acid, alkyl glucoside, hydroxyethyl cellulose, nonoxynol-10, glycerin, sodium hydroxide, potassium iodide, purified water
Package Labeling:0.4Ml
Label (Label)
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