Active Ingredient
Povidone-Iodine USP 10%
Povidone-iodine Gel
FDA Label NDC 65517-0070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dukal Llc for the product Povidone-iodine Gel (NDC 65517-0070). 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, use, warnings, do not use, ask a doctor before use if injuries are, stop use and ask doctor, 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
Antiseptic
Use
Patient preoperative skin preparation. Helps to reduce bacteria that potentially can cause skin infection.
Warnings
For External Use Only
Do Not Use
- if allergic to iodine
- in the eyes
Ask A Doctor Before Use If Injuries Are
- deep or puncture wounds
- serious burn
Stop Use And Ask Doctor
- infection occurs
- redness, irritation or swelling develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center right away
Directions
apply product to skin as needed
Other Information
- 1% titratable iodine
- Avoid excessive heat
- Store at room temperature
- For hospital or professional use only
- Not made with natural rubber latex
Inactive Ingredients
Alkyl Glucoside, Citric Acid, Glycerin, Hydroxyethyl Cellulose, Nonoxynol-10, Potassium Iodide, Sodium hydroxide, Water
Principle Display Panel
Duka
Povidone-Iodine
Gel
Non-Sterile
Antispetic
Drug Facts
Active ingredient Purpose
Povidone Iodine USP 10% Antiseptic
Use Patient preoperative skin preparation. Helps to reduce bacteria
that potentially can cause skin infection.
1 fl oz (29.5ml) Do not re-use NDC-66517-0070-1 REF 916
916 (916 Povidone Iodine Gel Item China)
* Please review the disclaimer below.
