Drug Factsactive Ingredient
Povidone-Iodine 10%
(Equivalent to 1% titratable iodine)
Povidone Iodine 10% Liquid
FDA Label NDC 85786-702
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Povidone Iodine 10% (NDC 85786-702). 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 factsactive ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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
Purpose
First Aid Antiseptic
Uses
First aid to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do Not Use
■ in the eyes
■ over large areas of the body
■ for longer than 1 week unless directed by a doctor
■ on individuals who are allergic or sensitive to iodine
Ask A Doctor Before Use If You Have
■ deep or puncture wounds
■ animal bites
■ serious burns
Stop Use And Ask A Doctor If
■ the condition persists or gets worse
■ irritation or redness develops or persists
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 a small amount on the area 1 to 3 times daily
■ may be covered with sterile bandage
■ if bandaged let dry first
Other Information
■ store at room temperature, 20-25°C (68-77° F)
Inactive Ingredients
Citric acid, disodium phosphate, glycerin, nonoxynol-9, sodium hydroxide and purified water
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC 85786-702-08
DR. SIMI
Povidone Iodine
10% Topical Solution
FIRST AID ANTISEPTIC
Helps prevent infection in minor
• cuts • scrapes • burns
8 fl oz (237 mL)
Distributed by:
FARMACIAS DE SIMILARES TX LLC.
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
†Compare to Active Ingredient in Betadine®
†This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Betadine®.
* Please review the disclaimer below.
