Otc - Active Ingredient
Active Ingredient
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)
Good Care Povidone Iodine Pad
FDA Label NDC 50685-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dalian Goodwood Medical Care Ltd. for the product Good Care Povidone Iodine Pad (NDC 50685-007). 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, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses
- Health-care antiseptic for preparation of the skin prior to surgery
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use or apply in the eyes
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
- as a first aid antiseptic
- animal bites
- serious burns
Otc - Stop Use
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.
Dosage & Administration
Directions
For preparation of the skin prior to surgery clean the affected area, remove swab by the stick, apply to the operative site prior to surgery.
Storage And Handling
Other information
Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
Inactive Ingredient
Inactive ingredients
Purified water
Other
Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.
Made in China www.dl-goodwood.com
Package Label.Principal Display Panel
Good CarePovidone Iodine pad10% povidone iodineFor Disinfection Use
Pi10 (Povidoneiodinepad)
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