Active Ingredient
Povidone-Iodine USP 10%
Dukal Povidone-iodine Scrub Sponge Sticks Sponge
FDA Label NDC 65517-0040
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 Dukal Povidone-iodine Scrub Sponge Sticks (NDC 65517-0040). 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:, otc - ask doctor, otc - stop use, otc - keep out of reach of children, directions, 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 reduc bacteria that potentially can cause skin infection.
Warnings:
For external use only.
- Do not apply to persons allergic to iodine. Do not use in the eyes.
Otc - Ask Doctor
- Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Otc - Stop Use
Stop use and ask doctor if infection occurs, redness, irritation or swelling develops.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If swallowed or gets in eyes, 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, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate
Package Label.Principal Display Panel
911 (911 Pvp Scrub Sponge Sticks Item China)
Povidone-Iodine
Scrub Sponge
Sticks
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.
Warnings
For external use only.
Do no use if allergic to iodine, in the eyes
Sterile unless package is damagedor opened
2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0040-1 REF 911
Dukal REF 911
Povidone-Iodine
Scrub Scrub Sponge Sticks
Sterile
Antiseptic
For Professional and Hospital Use
8 Boxes Per Case
10 Pouches Per Pack
2 Per Pouch
Not Made with Natural Rubber Latex Do not re-use NDC 65517-0040-1
911 Case (911 Pvp Scrub Sponge Sticks Case China)
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