Active Ingredient
Povidone-Iodine USP 10%
Povidone-iodine Gel Swabstick Gel
FDA Label NDC 65517-0036
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 Swabstick (NDC 65517-0036). 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 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
Antispetic
Use
Antiseptic Skin Preparation
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 If
- 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
- see product box for additional directions
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, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water
Dukal Povidone-Iodine Gel Swabstick
Item (Dukal 899 Pvpgelswab Item China Rev2 01)
CORPORATION
NDC 65517-0036-1
REF 899
Hold Upright and Tear Here
POVIDONE-IODINE
Gel Swabstick
Ready Gel 1X™
4" (10.2cm)
Saturated Swabstick
Drug Facts
Active ingredients Purpose
Povidone Iodine USP 10% Antiseptic
Use Patient preoperative skin preparation: Helps to
reduce bacterial that potentially can cause skin infection
1/Pouch 2
Made in China D07310901 Rev2
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