FDA Label for Nanz Povidone Iodine 5% Solution
View Indications, Usage & Precautions
Nanz Povidone Iodine 5% Solution Product Label
The following document was submitted to the FDA by the labeler of this product 1201258 Ontario Inc. O/a Nanz Pharma. 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 Ingredients
10% Povidone Iodine Solution USP, (1% available Iodine)
Purpose:
Topical Healthcare Antiseptic
Uses
For preparation of the skin prior to surgery
Helps reduce bacteria that potentially can cause skin infection.
To treat minor skin cuts and abrasions.
Warnings
For external use only.
Ask a doctor before use if you have deep or puncture wounds serious burns
Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases
Do not use in the eyes
Do not use if you are allergic to povidone-iodine or any other ingredients in this preparation
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center right away.
Storage:
Store in dry and dark place at temperature not exceeding 30C. Do not freeze
Label for all sizes
Inactive Ingredients
Anhydrous dibasic sodium phosphate, citric acid monohydrate, glycerin, polyethylene glycol 1500, nonoxynol-3, potassium iodate, water
Manufactured And Marketed By:
1201258 Ontario Inc. Nanz Pharma
575 Granite Ct.
Pickering,ON
L1W 3K1
Directions:
Single use may prevent extrinsic contamination
Clean the operative site prior to surgery
Apply product and allow to dry
May be covered with a bandage
Stop Use And Ask A Doctor If:
Irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
Distributed By:
1201258 Ontario Inc. Nanz Pharma
575 Granite Court
Pickerin, Ontario
L1W 3K1
Canada
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