Active Ingredient:
Povidone Iodine USP 10%
Pvp-i Pouch Foil-foil Solution
FDA Label NDC 65517-0035
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 Pvp-i Pouch Foil-foil (NDC 65517-0035). 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 - do not use, 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:
For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.
Warnings:
For external use only.
Otc - Do Not Use
Do not apply to persons allergic to iodine. Do not use in the eyes.
- Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.
Otc - Stop Use
- Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
- Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
Directions:
Clean the area. Apply product to the operative site prior to surgery.
Other Information:
1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.
Inactive Ingredients:
Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.
Principal Display Panel - 3/4 Oz Case Label
DUKAL™
CORPORATION
REF 885-500
STERILE
POVIDONE-IODINE
SOLUTION 3/4 OUNCE
For Professional and Hospital Use
Not made with Natural Rubber Latex
500/Case
1/Pack
2
Manufactured For: DUKAL CORPORATION • (631) 656-3800
Ronkonkoma, NY 11779 • www.dukal.com
Made in China, Hecho en China, Fabriqué en Chine
(01) 40665973025047
Principal Display Panel (3/4 oz Case Label)
Principal Display Panel - 3/4 Oz Pouch Label
DUKAL™
CORPORATION
REF 885
NDC 65517-0035-1
STERILE
POVIDONE-IODINE
SOLUTION
3/4 OUNCE
ANTISEPTIC
STERILE
Principal Display Panel (3/4 oz Pouch Label)
Principal Display Panel - 1 Oz Case Label
Dukal®
Corporation
REF 886-250
NDC 65517-0035-2
STERILE
POVIDONE-IODINE
SOLUTION 1 OUNCE
For Professional and Hospital Use
Not Made with Natural Rubber Latex
250/Case
1/Pack
2
Manufactured For: DUKAL CORPORATION • (631) 656-3800
Ronkonkoma, NY 11779 • www.dukal.com
Made in China
(01) 40665973026570
Principal Display Panel (1 oz Case Label)
Principal Display Panel - 1 Oz Pouch Label
Dukal®
Corporation
REF 886
NDC 65517-0035-2
POVIDONE-IODINE
1 OZ SOLUTION
ANTISEPTIC
STERILE
Principal Display Panel (1 oz Pouch Label)
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