Otc - Active Ingredient
Active Ingredient
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)
Good Care Povidone Iodine
FDA Label NDC 50685-001
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 (NDC 50685-001). 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
- 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 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 longer than 1 week unless directed by a doctor Discontinue use if irritation and redness develop.
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.
For use as a first aid antiseptic clean the affected 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.
Storage And Handling
Other information
Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
Inactive Ingredient
Inactive ingredients
citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide
Other
Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.
3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100
Tel: +86-411-87857288
Made in China www.dl-goodwood.com
Package Label.Principal Display Panel
Good Care
Povidone Iodine, USP Swabsticks
Antiseptic Germicide
Povidone Iodine, USP Swabsticks
Antiseptic Germicide
- Topical pre-surgical and first aid antiseptic swabstick
- For hospital and professional use only
Pis1 (Povidoneiodineswabsticks1per)
* Please review the disclaimer below.
