Active Ingredient
Povidon-Iodin 10% (w/w)
(equivalent to 1% titratable iodine)
Povidone-iodine Prep
FDA Label NDC 44019-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yinjing Medical Technology (shanghai) Co., Ltd. for the product Povidone-iodine Prep (NDC 44019-100). 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, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
- First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings
- For external use only
Do Not Use
- in the eyes or apply over large areas of the body
- longer than 1 week unless directed by a doctor
- on individuals who are sensitive or allergic to iodine
Stop Use And Ask A Doctor If
- irritation and redness develop
- condition persists more than 72 hours
- in case of deep or puncture wounds, animal bites or serious burns
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- Clean the treatment 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
Inactive Ingredient
- Purified water
Other Information
- Store at room temperature: 15°C~30°C(59°F~86°F)
- Avoid excessive heat
* Please review the disclaimer below.
