Active Ingredient:
Povidone-Iodine USP 10%
Pvp-iodine Swabstick Threes Swab
FDA Label NDC 65517-0033
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-iodine Swabstick Threes (NDC 65517-0033). 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:
For preparation prior to surgery. Helps to reduce bacteria that can potentially 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 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 using sponge sticks to prep desired area.
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 - Pvp-I Prep Swabstick Sterile 883-500 Pouch Label
DUKAL™
CORPORATION
REF 883
STERILE
POVIDONE-IODINE
SWABSTICKS
For Professional and Hospital Use
Not Made with Natural Rubber Latex
3
/Pouch
2
Manufactured For:
DUKAL CORPORATION • (631) 656-3800
Ronkonkoma, NY 11779 • www.dukal.com
Made in China
D02221801
Principal Display Panel (PVP-I Prep Swabstick Sterile 883-500 Pouch Label)
Principal Display Panel - Pvp-I Prep Swabstick Sterile 883-500 Case Label
DUKAL™
CORPORATION
REF 883-500
STERILE
POVIDONE-IODINE
SWABSTICKS
For Professional and Hospital Use
Not Made with Natural Rubber Latex
500/Case
3/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) 40665973024989
Principal Display Panel (PVP-I Prep Swabstick Sterile 883-500 Case Label)
Principal Display Panel - Pvp-I Prep Swabstick Sterile 884-1000 Pouch Label
DUKAL™
CORPORATION
REF 884
STERILE
POVIDONE
IODINE
SWABSTICK
For Professional and Hospital Use
Not Made with Natural Rubber Latex
1
/Pouch
2
Manufactured For:
DUKAL CORPORATION • (631) 656-3800
Ronkonkoma, NY 11779 • www.dukal.com
Made in China
D02231801
Principal Display Panel (PVP-I Prep Swabstick Sterile 884-1000 Pouch Label)
Principal Display Panel - Pvp-I Prep Swabstick Sterile 884-1000 Case Label
DUKAL™
CORPORATION
REF 884-1000
STERILE
POVIDONE-IODINE
SWABSTICKS
For Professional and Hospital Use
Not Made with Natural Rubber Latex
1000/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) 40665973025009
Principal Display Panel (PVP-I Prep Swabstick Sterile 884-1000 Case Label)
Principal Display Panel - Pvp-I Prep Swabsticks Sterile 883 Carton Label
DUKAL™
CORPORATION
REF 883
STERILE
POVIDONE-IODINE
SWABSTICKS
For Professional and Hospital Use
Not Made with Natural Rubber Latex
25
/box
3/pouch
2
Manufactured For: DUKAL CORPORATION • (631) 656-3800
Ronkonkoma, NY 11779 • www.dukal.com
Made in China, Hecho en China, Fabriqué en Chine
D02221802
Principal Display Panel (PVP-I Prep Swabsticks Sterile 883 Carton Label)
Principal Display Panel - Pvp-I Prep Swabstick Sterile 883 Carton Case Label
DUKAL™
CORPORATION
REF 883
STERILE
POVIDONE-IODINE
SWABSTICKS
For Professional and Hospital Use
Not Made with Natural Rubber Latex
10 Boxes/Case
25 Packs/Box
3/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) 30665973024982
Principal Display Panel (PVP-I Prep Swabstick Sterile 883 Carton Case Label)
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