FDA Label for Povidone-iodine
View Indications, Usage & Precautions
Povidone-iodine Product Label
The following document was submitted to the FDA by the labeler of this product Mazza Healthcare, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Povidone-Iodine, USP, 10% v/v
(equivalent to 1% titratable iodine)
Purpose
Antiseptic
Use
- 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
- apply product on the area 1-3 times daily
- may be covered with a sterile bandage when dry
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 - 2000 Pouch Carton Label
MH
Mazza Healthcare
MODEL NO.: 02-050-00
DESCRIPTION: POVIDONE-IODINE PREP PADS, MEDIUM
NON-STERILE
QUANTITY: 1 CASE (2000 EACH)
LOT NO.:
MANUFACTURE DATE:
EXPIRY DATE:
MANUFACTURED FOR:
Mazza Healthcare, LLC
Bannockburn, IL 60015 • USA
MADE IN CHINA
NDC 81280-002-01
Principal Display Panel - 1 Prep Pad Pouch Label
MH
Mazza Healthcare
Povidone-Iodine
Prep Pad
NDC 81280-002-01
Antiseptic • Germicide
Medium • 2-Ply
Non-Sterile • Single Use Only
Reorder No. 02-050-00
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