Active Ingredient
Povidone-Iodine, USP, 10% v/v
(equivalent to 1% titratable iodine)
Povidone-iodine Swab
FDA Label NDC 81280-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mazza Healthcare, Llc for the product Povidone-iodine (NDC 81280-003). 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, uses, warnings, do not use, otc - ask doctor, otc - stop use, otc - 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
Uses
- health care antiseptic for preparation of the skin prior to surgery
- first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
Warnings
For external use only
Do Not Use
- in the eyes
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
- as first aid antiseptic longer than 1 week unless directed by doctor
Discontinue use if irritation and redness develop.
Otc - Ask Doctor
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and consult a doctor if the condition persists or gets worse.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean the affected area
- for preparation of the skin prior to surgery, apply product to the operative site
- apply product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other Information
Store at room temperature 59-86°F (15-30°C).
Inactive Ingredients
citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
Mazza Healthcare, LLC
1-877-629-9242
Principal Display Panel - 500 Pouch Carton Label
MH
Mazza Healthcare
MODEL NO.: 02-053-00
DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE
QUANTITY: 1 CASE (500 POUCHES X 3 EACH)
LOT NO.:
MANUFACTURE DATE:
EXPIRY DATE:
MANUFACTURED FOR:
Mazza Healthcare, LLC
Bannockburn, IL 60015 • USA
MADE IN CHINA
NDC 81280-003-03
Principal Display Panel (500 Pouch Carton Label)
MH
Mazza Healthcare
MODEL NO.: 02-051-00
DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE
QUANTITY: 1 CASE (500 POUCHES X 1 EACH)
LOT NO.:
MANUFACTURE DATE:
EXPIRY DATE:
MANUFACTURED FOR:
Mazza Healthcare, LLC
Bannockburn, IL 60015 • USA
MADE IN CHINA
NDC 81280-003-01
Principal Display Panel (500 Pouch Carton Label)
Principal Display Panel - 3 Applicators Pouch Label
MH
Mazza Healthcare
Povidone-Iodine Swabsticks
NDC 81280-003-03
Antiseptic • Germicide • 4” Saturated
Non-Sterile • Single Use Only
3/pouch
Reorder Number 02-053-00
Principal Display Panel (3 Applicators Pouch Label)
Principal Display Panel - 1 Applicator Pouch Label
MH
Mazza Healthcare
Povidone-Iodine Swabstick
NDC 81280-003-01
Antiseptic • Germicide • 4” Saturated
Non-Sterile • Single Use Only
1/pouch
Reorder Number 02-051-00
Principal Display Panel (1 Applicator Pouch Label)
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