Otc - Active Ingredient
Povidone-lodine 10% w/w (equivalent to iodine 1%)
Povidone-iodine Prep Pad Medium Sterile
FDA Label NDC 81636-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Xingheng Medical Supplies Co., Ltd. for the product Povidone-iodine Prep Pad Medium Sterile (NDC 81636-006). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - do not use, otc - stop use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Warnings
For external use only.
Otc - When Using
● Clean the affected area
● Apply product on the area 1-3times daily and discard
● May be covered with a sterile bandage when dry
Otc - Do Not Use
Do not use:
- in the eyes.
- apply over large areas of the body.
- on individuals who are allergic or sensitive to iodine.
Otc - Stop Use
Stop use and consult a doctor
- if the condition persists or gets worse.
- for use longer than 1week.
Otc - Ask Doctor
Ask a doctor in case of deep or puncture wounds, animal bites & serious burns.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away.
Inactive Ingredient
Sodium Bicarbonate, Polysorbate 20, Polyethylene Glycol 400, Potassium Iodate, Water
Dosage & Administration
Apply topically as needed to cleanse intendend area；
Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.
Indications & Usage
Use for preparation of skin prior to injection，apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be 1min.Please clean before disinfection.
* Please review the disclaimer below.
